Trial Outcomes & Findings for A Study Comparing Cardiovascular Effects of Ticagrelor Versus Placebo in Patients With Type 2 Diabetes Mellitus (NCT NCT01991795)

Participant milestones
Measure	Ticagrelor 60 mg Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.	Ticagrelor Placebo Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.
Overall Study STARTED	9645	9626
Overall Study COMPLETED	9496	9503
Overall Study NOT COMPLETED	149	123

Reasons for withdrawal
Measure	Ticagrelor 60 mg Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.	Ticagrelor Placebo Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.
Overall Study Lost to Follow-up	6	4
Overall Study Withdrawal by Subject	117	94
Overall Study Site prematurely closed by sponsor	26	25

Baseline characteristics by cohort
Measure	Ticagrelor 60 mg n=9619 Participants Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.	Ticagrelor Placebo n=9601 Participants Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.	Total n=19220 Participants Total of all reporting groups
Age, Continuous	66.3 Years STANDARD_DEVIATION 7.8 • n=99 Participants	66.3 Years STANDARD_DEVIATION 7.7 • n=107 Participants	66.3 Years STANDARD_DEVIATION 7.8 • n=206 Participants
Sex: Female, Male Female	3043 Participants n=99 Participants	2988 Participants n=107 Participants	6031 Participants n=206 Participants
Sex: Female, Male Male	6576 Participants n=99 Participants	6613 Participants n=107 Participants	13189 Participants n=206 Participants
Race/Ethnicity, Customized White	6838 Participants n=99 Participants	6858 Participants n=107 Participants	13696 Participants n=206 Participants
Race/Ethnicity, Customized Black or african american	205 Participants n=99 Participants	198 Participants n=107 Participants	403 Participants n=206 Participants
Race/Ethnicity, Customized Asian	2211 Participants n=99 Participants	2195 Participants n=107 Participants	4406 Participants n=206 Participants
Race/Ethnicity, Customized Native hawaiian or other pacific islander	7 Participants n=99 Participants	7 Participants n=107 Participants	14 Participants n=206 Participants
Race/Ethnicity, Customized American indian or alaska native	161 Participants n=99 Participants	152 Participants n=107 Participants	313 Participants n=206 Participants
Race/Ethnicity, Customized Other	197 Participants n=99 Participants	191 Participants n=107 Participants	388 Participants n=206 Participants
Region of Enrollment USA	1126 Participants n=99 Participants	1140 Participants n=107 Participants	2266 Participants n=206 Participants
Region of Enrollment Argentina	195 Participants n=99 Participants	199 Participants n=107 Participants	394 Participants n=206 Participants
Region of Enrollment Australia	94 Participants n=99 Participants	94 Participants n=107 Participants	188 Participants n=206 Participants
Region of Enrollment Austria	42 Participants n=99 Participants	45 Participants n=107 Participants	87 Participants n=206 Participants
Region of Enrollment Belgium	109 Participants n=99 Participants	108 Participants n=107 Participants	217 Participants n=206 Participants
Region of Enrollment Bulgaria	435 Participants n=99 Participants	443 Participants n=107 Participants	878 Participants n=206 Participants
Region of Enrollment Brazil	412 Participants n=99 Participants	399 Participants n=107 Participants	811 Participants n=206 Participants
Region of Enrollment Canada	364 Participants n=99 Participants	365 Participants n=107 Participants	729 Participants n=206 Participants
Region of Enrollment Chile	152 Participants n=99 Participants	148 Participants n=107 Participants	300 Participants n=206 Participants
Region of Enrollment China	456 Participants n=99 Participants	454 Participants n=107 Participants	910 Participants n=206 Participants
Region of Enrollment Colombia	68 Participants n=99 Participants	68 Participants n=107 Participants	136 Participants n=206 Participants
Region of Enrollment Czech Republic	304 Participants n=99 Participants	298 Participants n=107 Participants	602 Participants n=206 Participants
Region of Enrollment Germany	277 Participants n=99 Participants	270 Participants n=107 Participants	547 Participants n=206 Participants
Region of Enrollment Denmark	123 Participants n=99 Participants	120 Participants n=107 Participants	243 Participants n=206 Participants
Region of Enrollment Spain	170 Participants n=99 Participants	170 Participants n=107 Participants	340 Participants n=206 Participants
Region of Enrollment Finland	60 Participants n=99 Participants	58 Participants n=107 Participants	118 Participants n=206 Participants
Region of Enrollment France	85 Participants n=99 Participants	87 Participants n=107 Participants	172 Participants n=206 Participants
Region of Enrollment United Kingdom	123 Participants n=99 Participants	123 Participants n=107 Participants	246 Participants n=206 Participants
Region of Enrollment Hong Kong	76 Participants n=99 Participants	76 Participants n=107 Participants	152 Participants n=206 Participants
Region of Enrollment Hungary	306 Participants n=99 Participants	310 Participants n=107 Participants	616 Participants n=206 Participants
Region of Enrollment India	147 Participants n=99 Participants	145 Participants n=107 Participants	292 Participants n=206 Participants
Region of Enrollment Israel	60 Participants n=99 Participants	57 Participants n=107 Participants	117 Participants n=206 Participants
Region of Enrollment Italy	67 Participants n=99 Participants	63 Participants n=107 Participants	130 Participants n=206 Participants
Region of Enrollment Japan	246 Participants n=99 Participants	250 Participants n=107 Participants	496 Participants n=206 Participants
Region of Enrollment Korea, Republic Of	433 Participants n=99 Participants	437 Participants n=107 Participants	870 Participants n=206 Participants
Region of Enrollment Mexico	182 Participants n=99 Participants	182 Participants n=107 Participants	364 Participants n=206 Participants
Region of Enrollment Netherlands	242 Participants n=99 Participants	237 Participants n=107 Participants	479 Participants n=206 Participants
Region of Enrollment Norway	95 Participants n=99 Participants	96 Participants n=107 Participants	191 Participants n=206 Participants
Region of Enrollment Peru	91 Participants n=99 Participants	82 Participants n=107 Participants	173 Participants n=206 Participants
Region of Enrollment Philippines	47 Participants n=99 Participants	45 Participants n=107 Participants	92 Participants n=206 Participants
Region of Enrollment Poland	815 Participants n=99 Participants	821 Participants n=107 Participants	1636 Participants n=206 Participants
Region of Enrollment Romania	37 Participants n=99 Participants	43 Participants n=107 Participants	80 Participants n=206 Participants
Region of Enrollment Russia	561 Participants n=99 Participants	560 Participants n=107 Participants	1121 Participants n=206 Participants
Region of Enrollment Saudi Arabia	79 Participants n=99 Participants	76 Participants n=107 Participants	155 Participants n=206 Participants
Region of Enrollment Slovakia	122 Participants n=99 Participants	122 Participants n=107 Participants	244 Participants n=206 Participants
Region of Enrollment Sweden	110 Participants n=99 Participants	114 Participants n=107 Participants	224 Participants n=206 Participants
Region of Enrollment Thailand	115 Participants n=99 Participants	116 Participants n=107 Participants	231 Participants n=206 Participants
Region of Enrollment Turkey	113 Participants n=99 Participants	112 Participants n=107 Participants	225 Participants n=206 Participants
Region of Enrollment Taiwan, Province Of China	402 Participants n=99 Participants	401 Participants n=107 Participants	803 Participants n=206 Participants
Region of Enrollment Ukraine	399 Participants n=99 Participants	393 Participants n=107 Participants	792 Participants n=206 Participants
Region of Enrollment Viet Nam	129 Participants n=99 Participants	125 Participants n=107 Participants	254 Participants n=206 Participants
Region of Enrollment South Africa	150 Participants n=99 Participants	149 Participants n=107 Participants	299 Participants n=206 Participants

Outcome measures
Measure	Ticagrelor 60 mg n=9619 Participants Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.	Ticagrelor Placebo n=9601 Participants Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.
Composite of Cardiovascular (CV) Death, MI or Stroke	736 Number of participants with event	818 Number of participants with event

Outcome measures
Measure	Ticagrelor 60 mg n=9619 Participants Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.	Ticagrelor Placebo n=9601 Participants Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.
CV Death	364 Number of participants with event	357 Number of participants with event

Outcome measures
Measure	Ticagrelor 60 mg n=9619 Participants Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.	Ticagrelor Placebo n=9601 Participants Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.
MI	274 Number of participants with event	328 Number of participants with event

Outcome measures
Measure	Ticagrelor 60 mg n=9619 Participants Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.	Ticagrelor Placebo n=9601 Participants Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.
Ischaemic Stroke	152 Number of participants with event	191 Number of participants with event

Outcome measures
Measure	Ticagrelor 60 mg n=9619 Participants Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.	Ticagrelor Placebo n=9601 Participants Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.
All-cause Death	579 Number of participants with event	592 Number of participants with event

Outcome measures
Measure	Ticagrelor 60 mg n=9562 Participants Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.	Ticagrelor Placebo n=9531 Participants Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.
TIMI Major Bleeding Event (Primary Safety Objective)	206 Number of participants with event	100 Number of participants with event

Outcome measures
Measure	Ticagrelor 60 mg n=9562 Participants Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.	Ticagrelor Placebo n=9531 Participants Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.
TIMI Major or Minor Bleeding Event	285 Number of participants with event	129 Number of participants with event

Outcome measures
Measure	Ticagrelor 60 mg n=9562 Participants Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.	Ticagrelor Placebo n=9531 Participants Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.
PLATO Major Bleeding Event	310 Number of participants with event	145 Number of participants with event

Outcome measures
Measure	Ticagrelor 60 mg n=9562 Participants Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.	Ticagrelor Placebo n=9531 Participants Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.
Permanent Discontinuation of Study Medication Due to Any Bleeding Event	466 Number of participants with event	125 Number of participants with event

Blood and lymphatic system disorders

Abdominal lymphadenopathy

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Blood and lymphatic system disorders

Agranulocytosis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Blood and lymphatic system disorders

Anaemia

0.21%

20/9562 • Number of events 20 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.15%

14/9531 • Number of events 14 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Blood and lymphatic system disorders

Anaemia macrocytic

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Blood and lymphatic system disorders

Anaemia of chronic disease

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Blood and lymphatic system disorders

Anaemia of malignant disease

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Blood and lymphatic system disorders

Anaemia vitamin b12 deficiency

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Blood and lymphatic system disorders

Deficiency anaemia

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Blood and lymphatic system disorders

Disseminated intravascular coagulation

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Blood and lymphatic system disorders

Haemorrhagic anaemia

0.10%

10/9562 • Number of events 10 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Blood and lymphatic system disorders

Hypochromic anaemia

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Blood and lymphatic system disorders

Immune thrombocytopenic purpura

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Blood and lymphatic system disorders

Increased tendency to bruise

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Blood and lymphatic system disorders

Iron deficiency anaemia

0.27%

26/9562 • Number of events 26 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.06%

6/9531 • Number of events 6 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Blood and lymphatic system disorders

Leukocytosis

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Blood and lymphatic system disorders

Lymphadenopathy

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Blood and lymphatic system disorders

Microcytic anaemia

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Blood and lymphatic system disorders

Nephrogenic anaemia

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Blood and lymphatic system disorders

Neutropenia

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Blood and lymphatic system disorders

Normochromic normocytic anaemia

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Blood and lymphatic system disorders

Normocytic anaemia

0.02%

2/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Blood and lymphatic system disorders

Pancytopenia

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Blood and lymphatic system disorders

Splenic infarction

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Blood and lymphatic system disorders

Spontaneous haematoma

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Blood and lymphatic system disorders

Spontaneous haemorrhage

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Blood and lymphatic system disorders

Thrombocytopenia

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Acute coronary syndrome

0.21%

20/9562 • Number of events 20 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.23%

22/9531 • Number of events 22 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Acute left ventricular failure

0.05%

5/9562 • Number of events 6 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Acute myocardial infarction

1.3%

126/9562 • Number of events 133 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

2.1%

197/9531 • Number of events 203 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Adams-stokes syndrome

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Angina pectoris

2.1%

200/9562 • Number of events 239 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

2.6%

251/9531 • Number of events 267 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Angina unstable

3.7%

354/9562 • Number of events 403 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

4.2%

405/9531 • Number of events 449 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Aortic valve disease

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Aortic valve incompetence

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Aortic valve stenosis

0.08%

8/9562 • Number of events 8 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.15%

14/9531 • Number of events 14 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Arrhythmia

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Arteriosclerosis coronary artery

0.09%

9/9562 • Number of events 9 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.08%

8/9531 • Number of events 8 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Atrial fibrillation

0.86%

82/9562 • Number of events 84 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.80%

76/9531 • Number of events 80 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Atrial flutter

0.13%

12/9562 • Number of events 13 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.14%

13/9531 • Number of events 14 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Atrial tachycardia

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.04%

4/9531 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Atrial thrombosis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Atrioventricular block

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Atrioventricular block complete

0.17%

16/9562 • Number of events 16 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.19%

18/9531 • Number of events 18 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Atrioventricular block first degree

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Atrioventricular block second degree

0.13%

12/9562 • Number of events 12 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.06%

6/9531 • Number of events 6 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Bifascicular block

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Bradyarrhythmia

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Bradycardia

0.16%

15/9562 • Number of events 15 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.06%

6/9531 • Number of events 6 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Bundle branch block left

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Bundle branch block right

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Cardiac arrest

0.07%

7/9562 • Number of events 7 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.13%

12/9531 • Number of events 12 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Cardiac disorder

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Cardiac failure

0.67%

64/9562 • Number of events 84 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.91%

87/9531 • Number of events 108 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Cardiac failure acute

0.21%

20/9562 • Number of events 27 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.15%

14/9531 • Number of events 15 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Cardiac failure chronic

0.19%

18/9562 • Number of events 19 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.31%

30/9531 • Number of events 44 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Cardiac failure congestive

0.63%

60/9562 • Number of events 71 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.49%

47/9531 • Number of events 53 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Cardiac tamponade

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Cardiac valve disease

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Cardiac ventricular scarring

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Cardio-respiratory arrest

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Cardiogenic shock

0.06%

6/9562 • Number of events 6 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.04%

4/9531 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Cardiomyopathy

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Cardiopulmonary failure

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Cardiovascular insufficiency

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Coronary artery disease

0.89%

85/9562 • Number of events 89 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.94%

90/9531 • Number of events 95 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Coronary artery insufficiency

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Coronary artery occlusion

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Coronary artery stenosis

0.15%

14/9562 • Number of events 14 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.04%

4/9531 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Dressler's syndrome

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Extrasystoles

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Hypertensive heart disease

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Ischaemic cardiomyopathy

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Left ventricular dysfunction

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Left ventricular failure

0.07%

7/9562 • Number of events 8 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.04%

4/9531 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Microvascular coronary artery disease

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Mitral valve incompetence

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Mitral valve stenosis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Myocardial fibrosis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Myocardial infarction

0.43%

41/9562 • Number of events 43 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.68%

65/9531 • Number of events 66 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Myocardial ischaemia

0.38%

36/9562 • Number of events 37 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.49%

47/9531 • Number of events 50 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Myocarditis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Nodal arrhythmia

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Palpitations

0.04%

4/9562 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Pericardial effusion

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Pericardial haemorrhage

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Pericarditis

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Pericarditis constrictive

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Prinzmetal angina

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Pulmonary valve incompetence

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Right ventricular failure

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Sinoatrial block

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Sinus arrhythmia

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Sinus bradycardia

0.07%

7/9562 • Number of events 7 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.04%

4/9531 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Sinus node dysfunction

0.05%

5/9562 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.04%

4/9531 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Sinus tachycardia

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Stress cardiomyopathy

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Supraventricular extrasystoles

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Supraventricular tachycardia

0.05%

5/9562 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.09%

9/9531 • Number of events 11 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Tachycardia

0.01%

1/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.04%

4/9531 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Tricuspid valve incompetence

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Ventricular arrhythmia

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Ventricular asystole

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Ventricular extrasystoles

0.04%

4/9562 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.07%

7/9531 • Number of events 7 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Ventricular fibrillation

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Cardiac disorders

Ventricular tachycardia

0.10%

10/9562 • Number of events 10 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.06%

6/9531 • Number of events 6 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Congenital, familial and genetic disorders

Corneal dystrophy

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Congenital, familial and genetic disorders

Glucose-6-phosphate dehydrogenase deficiency

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Congenital, familial and genetic disorders

Neurofibromatosis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Ear and labyrinth disorders

Deafness

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Ear and labyrinth disorders

Deafness neurosensory

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Ear and labyrinth disorders

Deafness unilateral

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Ear and labyrinth disorders

Ear pain

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Ear and labyrinth disorders

Eustachian tube dysfunction

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Ear and labyrinth disorders

Hypoacusis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Ear and labyrinth disorders

Inner ear disorder

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Ear and labyrinth disorders

Meniere's disease

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Ear and labyrinth disorders

Sudden hearing loss

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Ear and labyrinth disorders

Tinnitus

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Ear and labyrinth disorders

Tympanic membrane perforation

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Ear and labyrinth disorders

Tympanosclerosis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Ear and labyrinth disorders

Vertigo

0.14%

13/9562 • Number of events 13 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.07%

7/9531 • Number of events 7 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Ear and labyrinth disorders

Vertigo positional

0.07%

7/9562 • Number of events 7 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Ear and labyrinth disorders

Vestibular disorder

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Endocrine disorders

Adrenal insufficiency

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Endocrine disorders

Goitre

0.05%

5/9562 • Number of events 6 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Endocrine disorders

Hyperparathyroidism

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Endocrine disorders

Hyperparathyroidism primary

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Endocrine disorders

Hyperthyroidism

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Endocrine disorders

Hypothyroidism

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Endocrine disorders

Thyroiditis subacute

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Eye disorders

Age-related macular degeneration

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Eye disorders

Aphakia

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Eye disorders

Cataract

0.23%

22/9562 • Number of events 26 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.31%

30/9531 • Number of events 35 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Eye disorders

Cataract cortical

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Eye disorders

Cataract diabetic

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Eye disorders

Cataract nuclear

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Eye disorders

Corneal degeneration

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Eye disorders

Diabetic retinopathy

0.03%

3/9562 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.04%

4/9531 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Eye disorders

Entropion

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Eye disorders

Eye haemorrhage

0.04%

4/9562 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Eye disorders

Eyelid ptosis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Eye disorders

Glaucoma

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Eye disorders

Lacrimal disorder

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Eye disorders

Macular degeneration

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Eye disorders

Macular fibrosis

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Eye disorders

Macular oedema

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Eye disorders

Macular pseudohole

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Eye disorders

Maculopathy

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Eye disorders

Open angle glaucoma

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Eye disorders

Optic ischaemic neuropathy

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Eye disorders

Retinal artery occlusion

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Eye disorders

Retinal artery thrombosis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Eye disorders

Retinal degeneration

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Eye disorders

Retinal detachment

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Eye disorders

Retinal haemorrhage

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.05%

5/9531 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Eye disorders

Retinal vein occlusion

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Eye disorders

Retinal vein thrombosis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Eye disorders

Retinopathy

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Eye disorders

Retinopathy proliferative

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Eye disorders

Rhegmatogenous retinal detachment

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Eye disorders

Strabismus

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Eye disorders

Trichiasis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Eye disorders

Ulcerative keratitis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Eye disorders

Visual impairment

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Eye disorders

Vitreous haemorrhage

0.09%

9/9562 • Number of events 9 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.05%

5/9531 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Eye disorders

Vitreous opacities

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Abdominal discomfort

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Abdominal distension

0.02%

2/9562 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Abdominal hernia

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Abdominal pain

0.07%

7/9562 • Number of events 7 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.04%

4/9531 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Abdominal pain lower

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Abdominal pain upper

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.05%

5/9531 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Abdominal wall haematoma

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Anal fissure

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Anal fistula

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Anal haemorrhage

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Anal inflammation

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Appendicitis noninfective

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Appendix disorder

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Ascites

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Barrett's oesophagus

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Bezoar

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Change of bowel habit

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Chronic gastritis

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.04%

4/9531 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Chronic gastrointestinal bleeding

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Coeliac disease

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Colitis

0.04%

4/9562 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.05%

5/9531 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Colitis ischaemic

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Constipation

0.04%

4/9562 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Dental caries

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Diabetic gastroparesis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Diaphragmatic hernia

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Diarrhoea

0.19%

18/9562 • Number of events 18 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.08%

8/9531 • Number of events 8 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Diverticular perforation

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Diverticulitis oesophageal

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Diverticulum

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Diverticulum intestinal

0.04%

4/9562 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.04%

4/9531 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Diverticulum intestinal haemorrhagic

0.05%

5/9562 • Number of events 6 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Duodenal polyp

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Duodenal ulcer

0.04%

4/9562 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Duodenal ulcer haemorrhage

0.07%

7/9562 • Number of events 8 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.04%

4/9531 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Duodenitis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Dyspepsia

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Dysphagia

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Enteritis

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.04%

4/9531 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Enterocolitis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Epigastric discomfort

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Erosive oesophagitis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Faecaloma

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Faeces discoloured

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Food poisoning

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Functional gastrointestinal disorder

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Gastric antral vascular ectasia

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Gastric disorder

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Gastric haemorrhage

0.06%

6/9562 • Number of events 6 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Gastric polyps

0.05%

5/9562 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.06%

6/9531 • Number of events 8 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Gastric ulcer

0.19%

18/9562 • Number of events 18 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.09%

9/9531 • Number of events 9 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Gastric ulcer haemorrhage

0.06%

6/9562 • Number of events 6 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Gastric ulcer perforation

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Gastritis

0.08%

8/9562 • Number of events 8 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.13%

12/9531 • Number of events 12 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Gastritis erosive

0.09%

9/9562 • Number of events 9 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Gastritis haemorrhagic

0.06%

6/9562 • Number of events 6 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Gastroduodenal ulcer

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Gastrointestinal angiodysplasia

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Gastrointestinal disorder

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Gastrointestinal haemorrhage

0.45%

43/9562 • Number of events 44 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.23%

22/9531 • Number of events 23 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Gastrointestinal inflammation

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Gastrointestinal ischaemia

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Gastrointestinal motility disorder

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Gastrointestinal polyp haemorrhage

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Gastrointestinal stenosis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Gastrointestinal ulcer haemorrhage

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Gastrooesophageal reflux disease

0.05%

5/9562 • Number of events 6 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.07%

7/9531 • Number of events 7 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Haematemesis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Haematochezia

0.04%

4/9562 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Haemorrhagic erosive gastritis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Haemorrhoidal haemorrhage

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Haemorrhoids

0.05%

5/9562 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Hernial eventration

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Hiatus hernia

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Ileus

0.04%

4/9562 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Ileus paralytic

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Incarcerated inguinal hernia

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Inguinal hernia

0.17%

16/9562 • Number of events 16 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.21%

20/9531 • Number of events 20 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Intestinal haemorrhage

0.06%

6/9562 • Number of events 6 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Intestinal ischaemia

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Intestinal obstruction

0.04%

4/9562 • Number of events 6 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.05%

5/9531 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Intestinal perforation

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Intestinal polyp

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Intestinal pseudo-obstruction

0.01%

1/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Intestinal strangulation

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Large intestinal haemorrhage

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Large intestine perforation

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Large intestine polyp

0.19%

18/9562 • Number of events 18 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.15%

14/9531 • Number of events 14 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Lower gastrointestinal haemorrhage

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Lumbar hernia

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Mallory-weiss syndrome

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Mechanical ileus

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Melaena

0.13%

12/9562 • Number of events 12 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.04%

4/9531 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Nausea

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Obstruction gastric

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Obstructive pancreatitis

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Oesophageal motility disorder

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Oesophageal spasm

0.01%

1/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Oesophageal ulcer

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Oesophageal ulcer haemorrhage

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Oesophagitis

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Oesophagitis ulcerative

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Pancreatic mass

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Pancreatic pseudocyst

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Pancreatitis

0.12%

11/9562 • Number of events 14 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.07%

7/9531 • Number of events 7 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Pancreatitis acute

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.05%

5/9531 • Number of events 6 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Pancreatitis chronic

0.04%

4/9562 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Pancreatolithiasis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Peptic ulcer

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Peptic ulcer haemorrhage

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Periodontal disease

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Peritoneal adhesions

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Peritoneal haemorrhage

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Proctitis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Rectal haemorrhage

0.14%

13/9562 • Number of events 13 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Rectal polyp

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Rectal prolapse

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Reflux gastritis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Salivary gland calculus

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Small intestinal haemorrhage

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Small intestinal obstruction

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.04%

4/9531 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Subileus

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Swollen tongue

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Tooth disorder

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Tooth socket haemorrhage

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Ulcerative gastritis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Umbilical hernia

0.04%

4/9562 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Umbilical hernia, obstructive

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Upper gastrointestinal haemorrhage

0.23%

22/9562 • Number of events 23 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.10%

10/9531 • Number of events 10 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Varices oesophageal

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Gastrointestinal disorders

Vomiting

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

General disorders

Administration site phlebitis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

General disorders

Asthenia

0.04%

4/9562 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

General disorders

Capsular contracture associated with breast implant

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

General disorders

Cardiac death

0.04%

4/9562 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

General disorders

Catheter site haemorrhage

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

General disorders

Chest discomfort

0.05%

5/9562 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

General disorders

Chest pain

0.06%

6/9562 • Number of events 6 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.12%

11/9531 • Number of events 11 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

General disorders

Complication associated with device

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

General disorders

Death

0.54%

52/9562 • Number of events 52 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.63%

60/9531 • Number of events 60 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

General disorders

Drowning

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

General disorders

Facial pain

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

General disorders

Fatigue

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

General disorders

Foreign body reaction

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

General disorders

Gait disturbance

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

General disorders

Gait inability

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

General disorders

General physical health deterioration

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

General disorders

Impaired healing

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

General disorders

Medical device site haemorrhage

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

General disorders

Mucosal exfoliation

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

General disorders

Multiple organ dysfunction syndrome

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

General disorders

Necrobiosis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

General disorders

Necrosis

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

General disorders

Nodule

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

General disorders

Non-cardiac chest pain

0.56%

54/9562 • Number of events 60 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.69%

66/9531 • Number of events 72 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

General disorders

Oedema

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

General disorders

Oedema peripheral

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.04%

4/9531 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

General disorders

Pacemaker generated arrhythmia

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

General disorders

Pain

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

General disorders

Peripheral swelling

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

General disorders

Pyrexia

0.08%

8/9562 • Number of events 8 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.06%

6/9531 • Number of events 6 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

General disorders

Sudden cardiac death

0.06%

6/9562 • Number of events 6 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.08%

8/9531 • Number of events 8 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

General disorders

Sudden death

0.05%

5/9562 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.05%

5/9531 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

General disorders

Ulcer haemorrhage

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

General disorders

Vascular stent occlusion

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

General disorders

Vascular stent stenosis

0.06%

6/9562 • Number of events 6 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.04%

4/9531 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Hepatobiliary disorders

Acute hepatic failure

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Hepatobiliary disorders

Bile duct obstruction

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Hepatobiliary disorders

Bile duct stone

0.07%

7/9562 • Number of events 7 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Hepatobiliary disorders

Biliary colic

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Hepatobiliary disorders

Biliary dyskinesia

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Hepatobiliary disorders

Cholangitis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.04%

4/9531 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Hepatobiliary disorders

Cholangitis acute

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Hepatobiliary disorders

Cholangitis chronic

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Hepatobiliary disorders

Cholecystitis

0.14%

13/9562 • Number of events 14 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.24%

23/9531 • Number of events 27 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Hepatobiliary disorders

Cholecystitis acute

0.20%

19/9562 • Number of events 19 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.15%

14/9531 • Number of events 15 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Hepatobiliary disorders

Cholecystitis chronic

0.05%

5/9562 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.06%

6/9531 • Number of events 6 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Hepatobiliary disorders

Cholelithiasis

0.24%

23/9562 • Number of events 24 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.26%

25/9531 • Number of events 25 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Hepatobiliary disorders

Cholestasis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Hepatobiliary disorders

Chronic hepatitis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Hepatobiliary disorders

Cirrhosis alcoholic

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Hepatobiliary disorders

Drug-induced liver injury

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Hepatobiliary disorders

Gallbladder disorder

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Hepatobiliary disorders

Hepatic cirrhosis

0.04%

4/9562 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.07%

7/9531 • Number of events 7 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Hepatobiliary disorders

Hepatic failure

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Hepatobiliary disorders

Hepatic function abnormal

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Hepatobiliary disorders

Hepatitis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Hepatobiliary disorders

Hepatitis acute

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Hepatobiliary disorders

Jaundice

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Hepatobiliary disorders

Jaundice cholestatic

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Hepatobiliary disorders

Liver injury

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Hepatobiliary disorders

Non-alcoholic steatohepatitis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Hepatobiliary disorders

Portal vein thrombosis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Hepatobiliary disorders

Steatohepatitis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Immune system disorders

Allergy to arthropod bite

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Immune system disorders

Anaphylactic reaction

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.04%

4/9531 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Immune system disorders

Anaphylactic shock

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Immune system disorders

Contrast media allergy

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Immune system disorders

Drug hypersensitivity

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.04%

4/9531 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Immune system disorders

Haemophagocytic lymphohistiocytosis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Immune system disorders

Sarcoidosis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Immune system disorders

Transplant rejection

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Abdominal abscess

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Abdominal sepsis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Abdominal wall abscess

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Abscess jaw

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Abscess limb

0.05%

5/9562 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Abscess neck

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Acinetobacter infection

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Acute endocarditis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Acute hepatitis b

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Acute sinusitis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Anal abscess

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Anal fistula infection

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Appendiceal abscess

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Appendicitis

0.14%

13/9562 • Number of events 14 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.10%

10/9531 • Number of events 10 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Appendicitis perforated

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Arthritis infective

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Atypical pneumonia

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Bacteraemia

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Bacterial diarrhoea

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Bacterial sepsis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Biliary sepsis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Brain abscess

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Breast abscess

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Breast cellulitis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Bronchiolitis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Bronchitis

0.19%

18/9562 • Number of events 18 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.23%

22/9531 • Number of events 23 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Bronchitis bacterial

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Bursitis infective

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Campylobacter gastroenteritis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Cellulitis

0.37%

35/9562 • Number of events 40 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.47%

45/9531 • Number of events 51 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Cellulitis gangrenous

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Cellulitis of male external genital organ

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Cholangitis infective

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Cholecystitis infective

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Chronic hepatitis c

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Chronic sinusitis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Clostridium difficile colitis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Clostridium difficile infection

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Complicated appendicitis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Cystitis

0.04%

4/9562 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.04%

4/9531 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Dacryocystitis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Dengue fever

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Dengue haemorrhagic fever

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Device related infection

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Device related sepsis

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Diabetic foot infection

0.03%

3/9562 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Diabetic gangrene

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Diarrhoea infectious

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Diverticulitis

0.12%

11/9562 • Number of events 12 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.04%

4/9531 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Diverticulitis intestinal haemorrhagic

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Dysentery

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Ear infection

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Emphysematous cystitis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Endocarditis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.05%

5/9531 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Endophthalmitis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Enteritis infectious

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Enterobacter pneumonia

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Enterocolitis infectious

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Epididymitis

0.04%

4/9562 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Epiglottitis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Erysipelas

0.13%

12/9562 • Number of events 12 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.10%

10/9531 • Number of events 13 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Escherichia urinary tract infection

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Eye infection viral

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Febrile infection

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Fungal infection

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Gangrene

0.05%

5/9562 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.13%

12/9531 • Number of events 13 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Gastroenteritis

0.15%

14/9562 • Number of events 15 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.19%

18/9531 • Number of events 19 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Gastroenteritis bacterial

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Gastroenteritis salmonella

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Gastroenteritis viral

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Gastrointestinal infection

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Genitourinary tract infection

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Graft infection

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Groin abscess

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

H1n1 influenza

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Helicobacter gastritis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Helicobacter infection

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Hepatitis a

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Hepatitis c

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Hepatitis e

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Herpes ophthalmic

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Herpes virus infection

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Herpes zoster

0.05%

5/9562 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.05%

5/9531 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Incision site abscess

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Infected bite

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Infected cyst

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Infected dermal cyst

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Infected skin ulcer

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Infection

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Infectious colitis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Infectious pleural effusion

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Infective exacerbation of bronchiectasis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Infective exacerbation of chronic obstructive airways disease

0.01%

1/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Influenza

0.08%

8/9562 • Number of events 8 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.10%

10/9531 • Number of events 10 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Joint abscess

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Kidney infection

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Labyrinthitis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Liver abscess

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Localised infection

0.07%

7/9562 • Number of events 8 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.07%

7/9531 • Number of events 8 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Lower respiratory tract infection

0.04%

4/9562 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.05%

5/9531 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Ludwig angina

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Lung abscess

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Lung infection

0.10%

10/9562 • Number of events 12 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.06%

6/9531 • Number of events 7 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Meningitis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Meningitis bacterial

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Meningococcal infection

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Necrotising fasciitis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Neutropenic sepsis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Oesophageal candidiasis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Ophthalmic herpes zoster

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Orchitis

0.05%

5/9562 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Osteomyelitis

0.15%

14/9562 • Number of events 16 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.07%

7/9531 • Number of events 8 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Osteomyelitis acute

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Osteomyelitis chronic

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Otitis media

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Otitis media acute

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Otitis media chronic

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Pancreas infection

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Papilloma viral infection

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Parainfluenzae virus infection

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Parotitis

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Perineal abscess

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Periodontitis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Periorbital cellulitis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Peritonitis

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Peritonitis bacterial

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Peritonsillar abscess

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Pharyngeal abscess

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Pneumocystis jirovecii infection

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Pneumonia

1.4%

130/9562 • Number of events 137 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

1.5%

147/9531 • Number of events 153 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Pneumonia bacterial

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Pneumonia escherichia

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Pneumonia influenzal

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Pneumonia mycoplasmal

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Pneumonia staphylococcal

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Pneumonia streptococcal

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Pneumonia viral

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Post procedural infection

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Post procedural sepsis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Postoperative abscess

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Postoperative wound infection

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.07%

7/9531 • Number of events 7 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Prostatic abscess

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Prostatitis escherichia coli

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Pyelonephritis

0.08%

8/9562 • Number of events 8 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.04%

4/9531 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Pyelonephritis acute

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.13%

12/9531 • Number of events 12 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Pyelonephritis chronic

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Rectal abscess

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Respiratory tract infection

0.04%

4/9562 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.05%

5/9531 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Respiratory tract infection viral

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Salmonellosis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Scrotal abscess

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Sepsis

0.15%

14/9562 • Number of events 15 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.21%

20/9531 • Number of events 20 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Septic shock

0.07%

7/9562 • Number of events 7 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.07%

7/9531 • Number of events 7 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Sinusitis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Skin infection

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Soft tissue infection

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Staphylococcal infection

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Staphylococcal sepsis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Streptococcal infection

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Streptococcal sepsis

0.04%

4/9562 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Subcutaneous abscess

0.02%

2/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Tonsillitis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Tooth abscess

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Tracheobronchitis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Tracheobronchitis mycoplasmal

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Tuberculosis

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Tuberculosis of genitourinary system

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Upper respiratory tract infection

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.05%

5/9531 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Ureteritis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Urinary tract infection

0.35%

33/9562 • Number of events 37 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.38%

36/9531 • Number of events 50 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Urinary tract infection bacterial

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Urosepsis

0.13%

12/9562 • Number of events 13 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.10%

10/9531 • Number of events 11 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Vestibular neuronitis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Viral infection

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.06%

6/9531 • Number of events 6 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Vulval abscess

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Vulval cellulitis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

West nile viral infection

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Infections and infestations

Wound infection

0.05%

5/9562 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.04%

4/9531 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Abdominal injury

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Accident at home

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Acetabulum fracture

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Adrenal gland injury

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Anaemia postoperative

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Anastomotic leak

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Anastomotic stenosis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Ankle fracture

0.08%

8/9562 • Number of events 8 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.08%

8/9531 • Number of events 8 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Arterial bypass thrombosis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Arthropod bite

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Avulsion fracture

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Brain contusion

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Burns third degree

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Carbon monoxide poisoning

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Carotid artery restenosis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Cataract traumatic

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Cervical vertebral fracture

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Clavicle fracture

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Concussion

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Contusion

0.07%

7/9562 • Number of events 7 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.07%

7/9531 • Number of events 7 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Coronary artery restenosis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Coronary vascular graft occlusion

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Coronary vascular graft stenosis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Craniocerebral injury

0.05%

5/9562 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Dislocation of sternum

0.01%

1/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Epidural haemorrhage

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Extradural haematoma

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Extraskeletal ossification

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Facial bones fracture

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Failure to anastomose

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Fall

0.05%

5/9562 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Femoral neck fracture

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.04%

4/9531 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Femur fracture

0.08%

8/9562 • Number of events 8 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.16%

15/9531 • Number of events 15 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Fibula fracture

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Foot fracture

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.04%

4/9531 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Foreign body

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Foreign body in gastrointestinal tract

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Fracture

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Fractured sacrum

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Hand fracture

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Head injury

0.08%

8/9562 • Number of events 8 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Heat stroke

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Hip fracture

0.08%

8/9562 • Number of events 8 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.09%

9/9531 • Number of events 9 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Humerus fracture

0.13%

12/9562 • Number of events 12 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.08%

8/9531 • Number of events 8 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Hyphaema

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Incisional hernia

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Intervertebral disc injury

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Joint dislocation

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Joint injury

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.04%

4/9531 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Ligament injury

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Ligament rupture

0.04%

4/9562 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Ligament sprain

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Limb injury

0.13%

12/9562 • Number of events 13 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.07%

7/9531 • Number of events 8 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Lower limb fracture

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Lumbar vertebral fracture

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Lumbosacral plexus injury

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Median nerve injury

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Meniscus injury

0.09%

9/9562 • Number of events 9 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.05%

5/9531 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Multiple fractures

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Multiple injuries

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Muscle injury

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Muscle strain

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Nail injury

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Nerve injury

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Nerve root injury

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Nerve root injury lumbar

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Overdose

0.01%

1/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Patella fracture

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Pelvic fracture

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Periorbital haemorrhage

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Periprocedural myocardial infarction

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Post procedural complication

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Post procedural fever

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Post procedural haematoma

0.04%

4/9562 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Post procedural haemorrhage

0.12%

11/9562 • Number of events 11 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.05%

5/9531 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Postoperative ileus

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Postoperative respiratory failure

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Postoperative thoracic procedure complication

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Procedural complication

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Procedural haemorrhage

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Procedural pain

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Pubis fracture

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Pulmonary contusion

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Radiation pneumonitis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Radius fracture

0.06%

6/9562 • Number of events 7 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.08%

8/9531 • Number of events 8 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Rib fracture

0.04%

4/9562 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.10%

10/9531 • Number of events 10 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Road traffic accident

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Scapula fracture

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Seroma

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Shunt malfunction

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Skeletal injury

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Skin abrasion

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Skin injury

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Skin laceration

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.06%

6/9531 • Number of events 6 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Skull fracture

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Skull fractured base

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Spinal column injury

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Spinal compression fracture

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.07%

7/9531 • Number of events 7 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Spinal cord injury cervical

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Spinal fracture

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Sternal fracture

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Stomal hernia

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Subcutaneous haematoma

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Subdural haematoma

0.24%

23/9562 • Number of events 23 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.06%

6/9531 • Number of events 6 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Subdural haemorrhage

0.08%

8/9562 • Number of events 8 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.05%

5/9531 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Tendon injury

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Tendon rupture

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.08%

8/9531 • Number of events 8 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Thermal burn

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Thoracic vertebral fracture

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Tibia fracture

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.06%

6/9531 • Number of events 6 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Toxicity to various agents

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Traumatic fracture

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Traumatic haematoma

0.07%

7/9562 • Number of events 7 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Traumatic haemorrhage

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Traumatic haemothorax

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Traumatic intracranial haemorrhage

0.12%

11/9562 • Number of events 11 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.07%

7/9531 • Number of events 7 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Ulna fracture

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Upper limb fracture

0.06%

6/9562 • Number of events 6 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Urinary retention postoperative

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Vascular graft complication

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Vascular graft thrombosis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Vascular pseudoaneurysm

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Wound

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Wound dehiscence

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Wound haemorrhage

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Wound necrosis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Injury, poisoning and procedural complications

Wrist fracture

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Investigations

Alanine aminotransferase increased

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Investigations

Bile output decreased

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Investigations

Blood follicle stimulating hormone increased

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Investigations

Blood glucose fluctuation

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Investigations

Blood glucose increased

0.05%

5/9562 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Investigations

Blood lactic acid increased

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Investigations

Blood potassium increased

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Investigations

Blood pressure increased

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Investigations

Blood urine present

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Investigations

Cardiac stress test abnormal

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.04%

4/9531 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Investigations

Electrocardiogram qrs complex prolonged

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Investigations

Electrocardiogram st segment depression

0.01%

1/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Investigations

Electrocardiogram abnormal

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Investigations

Glycosylated haemoglobin increased

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Investigations

Haemoglobin decreased

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Investigations

Heart rate irregular

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Investigations

Hepatic enzyme increased

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Investigations

Hepatitis b surface antigen positive

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Investigations

Occult blood positive

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Investigations

Oxygen saturation decreased

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Investigations

Prostatic specific antigen increased

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Investigations

Troponin increased

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Investigations

Weight decreased

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Investigations

White blood cell count decreased

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Metabolism and nutrition disorders

Decreased appetite

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Metabolism and nutrition disorders

Dehydration

0.06%

6/9562 • Number of events 7 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.05%

5/9531 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Metabolism and nutrition disorders

Diabetes mellitus

0.25%

24/9562 • Number of events 28 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.44%

42/9531 • Number of events 46 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Metabolism and nutrition disorders

Diabetes mellitus inadequate control

0.52%

50/9562 • Number of events 55 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.63%

60/9531 • Number of events 78 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Metabolism and nutrition disorders

Diabetic complication

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Metabolism and nutrition disorders

Diabetic ketoacidosis

0.10%

10/9562 • Number of events 11 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.12%

11/9531 • Number of events 13 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Metabolism and nutrition disorders

Diabetic metabolic decompensation

0.09%

9/9562 • Number of events 9 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.18%

17/9531 • Number of events 17 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Metabolism and nutrition disorders

Euglycaemic diabetic ketoacidosis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Metabolism and nutrition disorders

Fluid overload

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Metabolism and nutrition disorders

Gout

0.05%

5/9562 • Number of events 7 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.06%

6/9531 • Number of events 6 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Metabolism and nutrition disorders

Hypercalcaemia

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Metabolism and nutrition disorders

Hyperglycaemia

0.21%

20/9562 • Number of events 21 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.23%

22/9531 • Number of events 24 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Metabolism and nutrition disorders

Hyperglycaemic hyperosmolar nonketotic syndrome

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Metabolism and nutrition disorders

Hyperkalaemia

0.05%

5/9562 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.04%

4/9531 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Metabolism and nutrition disorders

Hypertriglyceridaemia

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Metabolism and nutrition disorders

Hypoglycaemia

0.35%

33/9562 • Number of events 39 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.26%

25/9531 • Number of events 26 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Metabolism and nutrition disorders

Hypokalaemia

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Metabolism and nutrition disorders

Hypomagnesaemia

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Metabolism and nutrition disorders

Hyponatraemia

0.05%

5/9562 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Metabolism and nutrition disorders

Hypophosphataemia

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Metabolism and nutrition disorders

Hypovolaemia

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Metabolism and nutrition disorders

Ketoacidosis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Metabolism and nutrition disorders

Lactic acidosis

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Metabolism and nutrition disorders

Metabolic acidosis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Metabolism and nutrition disorders

Obesity

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Metabolism and nutrition disorders

Type 2 diabetes mellitus

0.13%

12/9562 • Number of events 12 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.20%

19/9531 • Number of events 19 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Metabolism and nutrition disorders

Vitamin d deficiency

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Arthralgia

0.05%

5/9562 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.06%

6/9531 • Number of events 6 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Arthritis

0.04%

4/9562 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.05%

5/9531 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Arthritis reactive

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Arthropathy

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Back pain

0.10%

10/9562 • Number of events 11 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.15%

14/9531 • Number of events 15 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Bone pain

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Bursitis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.04%

4/9531 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Cervical spinal stenosis

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Chest wall mass

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Chondromalacia

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Compartment syndrome

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Costochondritis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Crystal arthropathy

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Diabetic amyotrophy

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Dupuytren's contracture

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Facial asymmetry

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Fistula

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Flank pain

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Foot deformity

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Gouty arthritis

0.04%

4/9562 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.05%

5/9531 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Gouty tophus

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Inguinal mass

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Intervertebral disc degeneration

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Intervertebral disc disorder

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Intervertebral disc protrusion

0.17%

16/9562 • Number of events 17 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.20%

19/9531 • Number of events 20 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Intervertebral disc space narrowing

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Joint contracture

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Joint swelling

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Loose body in joint

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Lumbar spinal stenosis

0.14%

13/9562 • Number of events 13 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.07%

7/9531 • Number of events 7 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Meniscal degeneration

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Muscle disorder

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Muscular weakness

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Musculoskeletal chest pain

0.09%

9/9562 • Number of events 9 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.16%

15/9531 • Number of events 15 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Musculoskeletal pain

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.09%

9/9531 • Number of events 9 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Myalgia

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Myofascitis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Myopathy

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Myositis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Neck pain

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Neuropathic arthropathy

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Osteoarthritis

0.49%

47/9562 • Number of events 51 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.58%

55/9531 • Number of events 57 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Osteochondrosis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Osteonecrosis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Osteopenia

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Osteoporosis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Osteoporotic fracture

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Osteorrhagia

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Pain in extremity

0.04%

4/9562 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Patellofemoral pain syndrome

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Pathological fracture

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Periarthritis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Polymyalgia rheumatica

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Pseudarthrosis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Psoriatic arthropathy

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Rhabdomyolysis

0.06%

6/9562 • Number of events 6 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Rheumatoid arthritis

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Rotator cuff syndrome

0.05%

5/9562 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.08%

8/9531 • Number of events 8 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Sacroiliitis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Scoliosis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Seronegative arthritis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Sjogren's syndrome

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Soft tissue disorder

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Spinal column stenosis

0.08%

8/9562 • Number of events 8 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.04%

4/9531 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Spinal ligament ossification

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Spinal osteoarthritis

0.06%

6/9562 • Number of events 6 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.12%

11/9531 • Number of events 12 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Spinal pain

0.05%

5/9562 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Spondylitis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Spondylolisthesis

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Synovial cyst

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Tendon disorder

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Musculoskeletal and connective tissue disorders

Tenosynovitis stenosans

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Abdominal neoplasm

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Acute myeloid leukaemia

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Acute promyelocytic leukaemia

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Adenocarcinoma

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Adenocarcinoma gastric

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Adenocarcinoma of colon

0.15%

14/9562 • Number of events 14 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.06%

6/9531 • Number of events 6 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Adenocarcinoma pancreas

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Adrenal adenoma

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Adrenal neoplasm

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Anal cancer

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

B-cell lymphoma

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

B-cell lymphoma stage i

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Basal cell carcinoma

0.05%

5/9562 • Number of events 6 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.09%

9/9531 • Number of events 10 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Benign gastric neoplasm

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Benign neoplasm of bladder

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Benign neoplasm of thyroid gland

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Benign ovarian tumour

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Bile duct cancer

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Bladder cancer

0.08%

8/9562 • Number of events 8 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.09%

9/9531 • Number of events 9 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Bladder cancer recurrent

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Bladder neoplasm

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.04%

4/9531 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Bladder transitional cell carcinoma

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.04%

4/9531 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Bladder transitional cell carcinoma stage ii

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Bone cancer metastatic

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Bowen's disease

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Brain neoplasm

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Brain neoplasm malignant

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Breast cancer

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Breast cancer female

0.09%

9/9562 • Number of events 9 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.04%

4/9531 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Breast cancer metastatic

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Breast neoplasm

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Bronchial carcinoma

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Carcinoid tumour

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Cerebellopontine angle tumour

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Cervix carcinoma recurrent

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Cervix carcinoma stage 0

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Cholangiocarcinoma

0.03%

3/9562 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Cholesteatoma

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Chordoma

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Chronic lymphocytic leukaemia

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Chronic myeloid leukaemia

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Clear cell renal cell carcinoma

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Colon adenoma

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.04%

4/9531 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Colon cancer

0.13%

12/9562 • Number of events 12 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.17%

16/9531 • Number of events 16 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Colon cancer metastatic

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Colon neoplasm

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Colorectal adenocarcinoma

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Colorectal cancer

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.04%

4/9531 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Cutaneous lymphoma

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Endometrial adenocarcinoma

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Endometrial cancer

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Endometrial cancer metastatic

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Endometrial cancer stage i

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Endometrial cancer stage ii

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Fibroadenoma of breast

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Fibrosarcoma

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Fibrous histiocytoma

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Gallbladder adenocarcinoma

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Gallbladder adenoma

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Gallbladder cancer

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Gallbladder neoplasm

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Gastric adenoma

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Gastric cancer

0.07%

7/9562 • Number of events 7 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.10%

10/9531 • Number of events 10 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Gastric neoplasm

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Gastrointestinal carcinoma

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Gastrointestinal lymphoma

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Gastrointestinal melanoma

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Gastrointestinal neoplasm

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Gastrointestinal stromal tumour

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Gastrointestinal tract adenoma

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Glioblastoma

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Hepatic cancer

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.04%

4/9531 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Hepatic cancer metastatic

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Hepatobiliary neoplasm

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Hepatocellular carcinoma

0.09%

9/9562 • Number of events 10 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.04%

4/9531 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Invasive breast carcinoma

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Invasive ductal breast carcinoma

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Large intestine benign neoplasm

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Laryngeal cancer

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Laryngeal neoplasm

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lentigo maligna

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Leukaemia

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lip and/or oral cavity cancer

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lip neoplasm malignant stage unspecified

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lipofibroma

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lipoma

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lung adenocarcinoma

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.06%

6/9531 • Number of events 6 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lung cancer metastatic

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lung neoplasm

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lung neoplasm malignant

0.15%

14/9562 • Number of events 14 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.21%

20/9531 • Number of events 20 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lymphoma

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Malignant melanoma

0.07%

7/9562 • Number of events 7 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.04%

4/9531 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Malignant neoplasm of renal pelvis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Malignant neoplasm of unknown primary site

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Malignant neoplasm papilla of vater

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Meningioma

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Meningioma benign

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastases to bone

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastases to central nervous system

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastases to liver

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastases to lung

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastases to peritoneum

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastases to pleura

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastatic gastric cancer

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastatic malignant melanoma

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastatic neoplasm

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Monoclonal gammopathy

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Muscle neoplasm

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Musculoskeletal cancer

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Myelodysplastic syndrome

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Nasopharyngeal cancer

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Neoplasm

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Neoplasm malignant

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Neoplasm prostate

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Non-hodgkin's lymphoma

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Non-small cell lung cancer

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Oesophageal adenocarcinoma

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Headache

0.01%

1/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Oesophageal carcinoma

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.04%

4/9531 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Oesophageal neoplasm

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Oral neoplasm benign

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Osteoma

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Ovarian cancer

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Ovarian fibroma

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Ovarian granulosa cell tumour

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Ovarian neoplasm

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Pancreatic carcinoma

0.13%

12/9562 • Number of events 13 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.13%

12/9531 • Number of events 12 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Pancreatic carcinoma metastatic

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Pancreatic neoplasm

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Pancreatic neuroendocrine tumour

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Pancreatic sarcoma

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Papillary cystadenoma lymphomatosum

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Hemianopia

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Papillary thyroid cancer

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Parathyroid tumour benign

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Penis carcinoma metastatic

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Phyllodes tumour

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Pituitary tumour

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Pituitary tumour benign

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Plasma cell myeloma

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Plasmacytoma

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Pleomorphic liposarcoma

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Pleural neoplasm

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Prostate cancer

0.32%

31/9562 • Number of events 31 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.38%

36/9531 • Number of events 36 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Prostate cancer metastatic

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.04%

4/9531 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Prostate cancer recurrent

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Prostate cancer stage 0

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Prostate cancer stage iii

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Prostatic adenoma

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Rectal adenocarcinoma

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Rectal cancer

0.09%

9/9562 • Number of events 9 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Rectal cancer recurrent

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Rectal neoplasm

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Rectosigmoid cancer

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Rectosigmoid cancer metastatic

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Renal cancer

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.07%

7/9531 • Number of events 7 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Renal cancer metastatic

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Renal cell carcinoma

0.05%

5/9562 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Renal neoplasm

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Retroperitoneal cancer

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Salivary gland adenoma

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Salivary gland neoplasm

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Skin cancer

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Small cell lung cancer

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Small cell lung cancer recurrent

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Small intestine adenocarcinoma

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Small intestine carcinoma

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Soft tissue sarcoma

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Squamous cell carcinoma

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Squamous cell carcinoma of lung

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Squamous cell carcinoma of skin

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Squamous cell carcinoma of the cervix

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Squamous cell carcinoma of the oral cavity

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Squamous cell carcinoma of the tongue

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Thyroid adenoma

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Thyroid cancer

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.05%

5/9531 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Thyroid cancer recurrent

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Thyroid neoplasm

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Tongue neoplasm malignant stage unspecified

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Tonsil cancer

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Transitional cell cancer of the renal pelvis and ureter

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Transitional cell carcinoma

0.04%

4/9562 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Tumour haemorrhage

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Uterine cancer

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Uterine leiomyoma

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Vulval cancer

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Ageusia

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Altered state of consciousness

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Amnesia

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Ataxia

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Balance disorder

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Basal ganglia haemorrhage

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Basal ganglia infarction

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Brain hypoxia

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Brain injury

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Brain stem haemorrhage

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Brain stem infarction

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Brain stem stroke

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Carotid arteriosclerosis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Carotid artery disease

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Carotid artery occlusion

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Carotid artery stenosis

0.19%

18/9562 • Number of events 18 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.22%

21/9531 • Number of events 22 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Carotid sinus syndrome

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Carpal tunnel syndrome

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Cauda equina syndrome

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Cerebellar haemorrhage

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Cerebellar infarction

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Cerebellar stroke

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Cerebral arteriosclerosis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Cerebral atrophy

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Cerebral haematoma

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Cerebral haemorrhage

0.06%

6/9562 • Number of events 6 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.06%

6/9531 • Number of events 6 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Cerebral infarction

0.19%

18/9562 • Number of events 19 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.28%

27/9531 • Number of events 28 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Cerebral ischaemia

0.07%

7/9562 • Number of events 9 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Cerebral small vessel ischaemic disease

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Cerebrovascular accident

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.09%

9/9531 • Number of events 9 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Cerebrovascular insufficiency

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Cervical cord compression

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Cervical radiculopathy

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Cervicobrachial syndrome

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Cluster headache

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Cognitive disorder

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Coma

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Dementia

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.04%

4/9531 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Dementia with lewy bodies

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Diabetic coma

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Diabetic neuropathy

0.09%

9/9562 • Number of events 10 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.14%

13/9531 • Number of events 14 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Dizziness

0.15%

14/9562 • Number of events 15 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.13%

12/9531 • Number of events 12 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Dysarthria

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Embolic cerebral infarction

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Embolic stroke

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Encephalopathy

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Epilepsy

0.01%

1/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.05%

5/9531 • Number of events 7 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Epileptic encephalopathy

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Essential tremor

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Facial paralysis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Focal dyscognitive seizures

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Generalised tonic-clonic seizure

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Haemorrhage intracranial

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.04%

4/9531 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Haemorrhagic stroke

0.10%

10/9562 • Number of events 10 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.09%

9/9531 • Number of events 9 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Haemorrhagic transformation stroke

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Hemiparesis

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Hepatic encephalopathy

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Hydrocephalus

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Hypertensive encephalopathy

0.05%

5/9562 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Hypoaesthesia

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Hypoglycaemic coma

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Hypoglycaemic encephalopathy

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Hypoglycaemic seizure

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Hypoglycaemic unconsciousness

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Iiird nerve paralysis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Intracranial aneurysm

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Intracranial pressure increased

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Ischaemic cerebral infarction

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Ischaemic stroke

0.89%

85/9562 • Number of events 88 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

1.2%

119/9531 • Number of events 127 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Lacunar infarction

0.09%

9/9562 • Number of events 10 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.05%

5/9531 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Lacunar stroke

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Loss of consciousness

0.04%

4/9562 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.04%

4/9531 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Lumbar radiculopathy

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Lumbosacral radiculopathy

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Metabolic encephalopathy

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Microsleep

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Migraine

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Miller fisher syndrome

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Myasthenia gravis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Myelopathy

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Nerve compression

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Neuropathy peripheral

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Normal pressure hydrocephalus

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Paraesthesia

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Paralysis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Parkinson's disease

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.07%

7/9531 • Number of events 8 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Parkinsonism

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Peripheral nerve lesion

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Petit mal epilepsy

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Polyneuropathy

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Post-traumatic headache

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Presyncope

0.05%

5/9562 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.04%

4/9531 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Pseudoradicular syndrome

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Putamen haemorrhage

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Radicular pain

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Radiculopathy

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Sciatica

0.04%

4/9562 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.09%

9/9531 • Number of events 9 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Sedation

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Seizure

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.06%

6/9531 • Number of events 7 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Spinal cord compression

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Spinal epidural haematoma

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Subarachnoid haemorrhage

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Syncope

0.27%

26/9562 • Number of events 29 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.28%

27/9531 • Number of events 28 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Tension headache

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Thalamic infarction

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Thalamus haemorrhage

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Thoracic outlet syndrome

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Toxic encephalopathy

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Transient global amnesia

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Transient ischaemic attack

0.41%

39/9562 • Number of events 39 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.35%

33/9531 • Number of events 34 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Tremor

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Vith nerve disorder

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Vith nerve paralysis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Vith nerve paresis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Vascular dementia

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Vascular encephalopathy

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Vertebral artery dissection

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Vertebral artery stenosis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Vertebrobasilar insufficiency

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Nervous system disorders

Vertigo cns origin

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Product Issues

Device dislocation

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Product Issues

Device failure

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Product Issues

Device loosening

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Product Issues

Device malfunction

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Product Issues

Device occlusion

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Psychiatric disorders

Adjustment disorder

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Psychiatric disorders

Affective disorder

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Psychiatric disorders

Anxiety

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Psychiatric disorders

Bipolar disorder

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Psychiatric disorders

Borderline personality disorder

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Psychiatric disorders

Completed suicide

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Psychiatric disorders

Confusional state

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Psychiatric disorders

Delirium

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Psychiatric disorders

Delirium tremens

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Psychiatric disorders

Depression

0.06%

6/9562 • Number of events 7 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.04%

4/9531 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Psychiatric disorders

Depression suicidal

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Psychiatric disorders

Disorientation

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Psychiatric disorders

Illness anxiety disorder

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Psychiatric disorders

Insomnia

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Psychiatric disorders

Major depression

0.01%

1/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Psychiatric disorders

Mental disorder

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Psychiatric disorders

Mental status changes

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Psychiatric disorders

Neuropsychiatric symptoms

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Psychiatric disorders

Suicide attempt

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Renal and urinary disorders

Acute kidney injury

0.59%

56/9562 • Number of events 59 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.41%

39/9531 • Number of events 43 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Renal and urinary disorders

Azotaemia

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Renal and urinary disorders

Bladder neck obstruction

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Renal and urinary disorders

Bladder neck sclerosis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Renal and urinary disorders

Bladder outlet obstruction

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Renal and urinary disorders

Bladder tamponade

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Renal and urinary disorders

Calculus bladder

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.07%

7/9531 • Number of events 7 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Renal and urinary disorders

Calculus urethral

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Renal and urinary disorders

Calculus urinary

0.06%

6/9562 • Number of events 7 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Renal and urinary disorders

Chronic kidney disease

0.09%

9/9562 • Number of events 10 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.16%

15/9531 • Number of events 15 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Renal and urinary disorders

Cystitis haemorrhagic

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Renal and urinary disorders

Diabetic nephropathy

0.06%

6/9562 • Number of events 6 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Renal and urinary disorders

Dysuria

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Renal and urinary disorders

End stage renal disease

0.04%

4/9562 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Renal and urinary disorders

Glomerulonephritis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Renal and urinary disorders

Glomerulosclerosis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Renal and urinary disorders

Haematuria

0.33%

32/9562 • Number of events 33 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.14%

13/9531 • Number of events 13 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Renal and urinary disorders

Haemorrhage urinary tract

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Renal and urinary disorders

Hydronephrosis

0.04%

4/9562 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.07%

7/9531 • Number of events 7 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Renal and urinary disorders

Hypertensive nephropathy

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Renal and urinary disorders

Micturition disorder

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Renal and urinary disorders

Nephritic syndrome

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Renal and urinary disorders

Nephrolithiasis

0.17%

16/9562 • Number of events 19 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.22%

21/9531 • Number of events 24 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Renal and urinary disorders

Nephropathy toxic

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Renal and urinary disorders

Nephrotic syndrome

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.04%

4/9531 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Renal and urinary disorders

Pelvi-ureteric obstruction

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Renal and urinary disorders

Perinephritis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Renal and urinary disorders

Proteinuria

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Renal and urinary disorders

Renal artery arteriosclerosis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Renal and urinary disorders

Renal artery occlusion

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Renal and urinary disorders

Renal artery stenosis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Renal and urinary disorders

Renal colic

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Renal and urinary disorders

Renal cyst

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Renal and urinary disorders

Renal disorder

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Renal and urinary disorders

Renal failure

0.17%

16/9562 • Number of events 17 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.16%

15/9531 • Number of events 15 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Renal and urinary disorders

Renal haemorrhage

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Renal and urinary disorders

Renal hypertension

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Renal and urinary disorders

Renal impairment

0.10%

10/9562 • Number of events 10 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.08%

8/9531 • Number of events 8 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Renal and urinary disorders

Renal injury

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Renal and urinary disorders

Renal mass

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Renal and urinary disorders

Stress urinary incontinence

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Renal and urinary disorders

Tubulointerstitial nephritis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Renal and urinary disorders

Ureteric stenosis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Renal and urinary disorders

Ureterolithiasis

0.19%

18/9562 • Number of events 20 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.14%

13/9531 • Number of events 14 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Renal and urinary disorders

Urethral haemorrhage

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Renal and urinary disorders

Urethral stenosis

0.05%

5/9562 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Renal and urinary disorders

Urinary bladder polyp

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Renal and urinary disorders

Urinary incontinence

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Renal and urinary disorders

Urinary retention

0.04%

4/9562 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.07%

7/9531 • Number of events 7 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Renal and urinary disorders

Urinary tract obstruction

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Reproductive system and breast disorders

Acquired hydrocele

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Reproductive system and breast disorders

Acquired phimosis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Reproductive system and breast disorders

Benign prostatic hyperplasia

0.27%

26/9562 • Number of events 26 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.22%

21/9531 • Number of events 21 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Reproductive system and breast disorders

Breast mass

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Reproductive system and breast disorders

Cervical dysplasia

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Reproductive system and breast disorders

Cervix disorder

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Reproductive system and breast disorders

Cystocele

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Reproductive system and breast disorders

Endometrial atrophy

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Reproductive system and breast disorders

Endometrial hyperplasia

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Reproductive system and breast disorders

Genital haemorrhage

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Reproductive system and breast disorders

Gynaecomastia

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Reproductive system and breast disorders

Ovarian cyst

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Reproductive system and breast disorders

Postmenopausal haemorrhage

0.01%

1/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Reproductive system and breast disorders

Prostatic fibrosis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Reproductive system and breast disorders

Prostatic haemorrhage

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Reproductive system and breast disorders

Prostatic obstruction

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Reproductive system and breast disorders

Prostatism

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Reproductive system and breast disorders

Prostatitis

0.07%

7/9562 • Number of events 7 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.05%

5/9531 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Reproductive system and breast disorders

Prostatomegaly

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Reproductive system and breast disorders

Uterine fibrosis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Reproductive system and breast disorders

Uterine haemorrhage

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Reproductive system and breast disorders

Uterine polyp

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Reproductive system and breast disorders

Uterine prolapse

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Reproductive system and breast disorders

Vaginal haemorrhage

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Reproductive system and breast disorders

Vaginal prolapse

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Acute pulmonary oedema

0.06%

6/9562 • Number of events 8 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.07%

7/9531 • Number of events 7 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Acute respiratory distress syndrome

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Acute respiratory failure

0.12%

11/9562 • Number of events 12 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.07%

7/9531 • Number of events 7 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Aspiration

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Asthma

0.15%

14/9562 • Number of events 18 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.07%

7/9531 • Number of events 9 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Asthmatic crisis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Bronchial disorder

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Bronchial obstruction

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Bronchiectasis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Bronchitis chronic

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Bronchospasm

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Choking

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Chronic obstructive pulmonary disease

0.28%

27/9562 • Number of events 41 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.43%

41/9531 • Number of events 57 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Chronic respiratory failure

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Diaphragmatic paralysis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Dyspnoea

0.37%

35/9562 • Number of events 36 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.30%

29/9531 • Number of events 29 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Dyspnoea exertional

0.05%

5/9562 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.08%

8/9531 • Number of events 8 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Emphysema

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Epiglottic cyst

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Epistaxis

0.21%

20/9562 • Number of events 20 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.12%

11/9531 • Number of events 12 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Haemoptysis

0.04%

4/9562 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Haemothorax

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Hydrothorax

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Idiopathic interstitial pneumonia

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Idiopathic pulmonary fibrosis

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Interstitial lung disease

0.03%

3/9562 • Number of events 6 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Laryngeal oedema

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Lung disorder

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Lung infiltration

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Mediastinal haemorrhage

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Nasal polyps

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Nasal septum deviation

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Obstructive airways disorder

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Organising pneumonia

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Orthopnoea

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Paranasal cyst

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Pleural effusion

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.05%

5/9531 • Number of events 6 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Pleurisy

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Pneumonia aspiration

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Pneumonitis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Pneumothorax

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Pneumothorax spontaneous

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Pulmonary arterial hypertension

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Pulmonary congestion

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Pulmonary embolism

0.17%

16/9562 • Number of events 16 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.20%

19/9531 • Number of events 19 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Pulmonary fibrosis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Pulmonary hypertension

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Pulmonary mass

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Pulmonary oedema

0.10%

10/9562 • Number of events 10 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.05%

5/9531 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Pulmonary sarcoidosis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Pulmonary toxicity

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Respiratory alkalosis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Respiratory arrest

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Respiratory disorder

0.01%

1/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Respiratory failure

0.08%

8/9562 • Number of events 9 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.08%

8/9531 • Number of events 8 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Restrictive pulmonary disease

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Sinus congestion

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Respiratory, thoracic and mediastinal disorders

Sleep apnoea syndrome

0.04%

4/9562 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Skin and subcutaneous tissue disorders

Actinic elastosis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Skin and subcutaneous tissue disorders

Angioedema

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Skin and subcutaneous tissue disorders

Decubitus ulcer

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Skin and subcutaneous tissue disorders

Dermal cyst

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Skin and subcutaneous tissue disorders

Dermatitis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Skin and subcutaneous tissue disorders

Diabetic foot

0.30%

29/9562 • Number of events 32 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.19%

18/9531 • Number of events 25 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Skin and subcutaneous tissue disorders

Diabetic ulcer

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Skin and subcutaneous tissue disorders

Ecchymosis

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Skin and subcutaneous tissue disorders

Eczema

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Skin and subcutaneous tissue disorders

Henoch-schonlein purpura

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Skin and subcutaneous tissue disorders

Intertrigo

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Skin and subcutaneous tissue disorders

Ischaemic skin ulcer

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Skin and subcutaneous tissue disorders

Lichen planus

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Skin and subcutaneous tissue disorders

Myxoid cyst

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Skin and subcutaneous tissue disorders

Necrobiosis lipoidica diabeticorum

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Skin and subcutaneous tissue disorders

Petechiae

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Skin and subcutaneous tissue disorders

Prurigo

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Skin and subcutaneous tissue disorders

Psoriasis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Skin and subcutaneous tissue disorders

Rash

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Skin and subcutaneous tissue disorders

Skin exfoliation

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Skin and subcutaneous tissue disorders

Skin mass

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Skin and subcutaneous tissue disorders

Skin necrosis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Skin and subcutaneous tissue disorders

Skin ulcer

0.07%

7/9562 • Number of events 7 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.13%

12/9531 • Number of events 12 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Skin and subcutaneous tissue disorders

Stevens-johnson syndrome

0.01%

1/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Skin and subcutaneous tissue disorders

Toxic skin eruption

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Skin and subcutaneous tissue disorders

Urticaria

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Accelerated hypertension

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Air embolism

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Angiopathy

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Aortic aneurysm

0.08%

8/9562 • Number of events 8 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.09%

9/9531 • Number of events 9 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Aortic arteriosclerosis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Aortic dissection

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Aortic stenosis

0.05%

5/9562 • Number of events 5 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.07%

7/9531 • Number of events 8 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Arterial occlusive disease

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Arterial stenosis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Arterial thrombosis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Arteriosclerosis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Artery dissection

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Atherosclerotic plaque rupture

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Blood pressure inadequately controlled

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Circulatory collapse

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Deep vein thrombosis

0.06%

6/9562 • Number of events 6 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.08%

8/9531 • Number of events 8 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Diabetic vascular disorder

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Embolism arterial

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Embolism venous

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Extremity necrosis

0.05%

5/9562 • Number of events 6 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Hypertension

0.38%

36/9562 • Number of events 40 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.47%

45/9531 • Number of events 45 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Hypertensive crisis

0.16%

15/9562 • Number of events 17 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.24%

23/9531 • Number of events 25 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Hypertensive emergency

0.04%

4/9562 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Hypotension

0.09%

9/9562 • Number of events 10 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.06%

6/9531 • Number of events 7 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Hypovolaemic shock

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Iliac artery disease

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Iliac artery embolism

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Intermittent claudication

0.09%

9/9562 • Number of events 9 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.07%

7/9531 • Number of events 8 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Labile blood pressure

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Lymphocele

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Lymphoedema

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Malignant hypertension

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Necrosis ischaemic

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Neurogenic shock

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Orthostatic hypotension

0.07%

7/9562 • Number of events 7 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Peripheral arterial occlusive disease

0.32%

31/9562 • Number of events 38 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.50%

48/9531 • Number of events 60 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Peripheral artery aneurysm

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Peripheral artery occlusion

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Peripheral artery stenosis

0.10%

10/9562 • Number of events 10 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.04%

4/9531 • Number of events 4 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Peripheral artery thrombosis

0.05%

5/9562 • Number of events 6 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.06%

6/9531 • Number of events 6 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Peripheral coldness

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Peripheral embolism

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Peripheral ischaemia

0.15%

14/9562 • Number of events 17 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.19%

18/9531 • Number of events 19 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Peripheral vascular disorder

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.05%

5/9531 • Number of events 6 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Peripheral venous disease

0.03%

3/9562 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.03%

3/9531 • Number of events 3 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Rheumatoid vasculitis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Shock

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Shock haemorrhagic

0.02%

2/9562 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Subclavian artery stenosis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Subgaleal haematoma

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Temporal arteritis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Thrombophlebitis

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Thrombophlebitis superficial

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Thrombosis

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Varicose vein

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Vascular compression

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.01%

1/9531 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Vascular occlusion

0.01%

1/9562 • Number of events 1 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.00%

0/9531 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Vascular disorders

Venous thrombosis limb

0.00%

0/9562 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

0.02%

2/9531 • Number of events 2 • All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

All-cause death was assessed for all randomised participants, except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor. Systematic assessment of suspected bleeding events, suspected endpoint events, SAEs, AEs that leads to permanent discontinuation of study drug and non-serious AEs of interest. The analysis set included all patients who received at least 1 dose of study drug, except those patients randomised at the prematurely closed site.

Trial Outcomes & Findings for A Study Comparing Cardiovascular Effects of Ticagrelor Versus Placebo in Patients With Type 2 Diabetes Mellitus (NCT NCT01991795)

Results Overview

Participant Flow

Participant milestones

Reasons for withdrawal

Baseline Characteristics

Baseline characteristics by cohort

PRIMARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

OTHER_PRE_SPECIFIED outcome

Outcome measures

OTHER_PRE_SPECIFIED outcome

Outcome measures

OTHER_PRE_SPECIFIED outcome

Outcome measures

OTHER_PRE_SPECIFIED outcome

Outcome measures

Adverse Events

Ticagrelor 60 mg

Ticagrelor Placebo

Serious adverse events

Other adverse events

Additional Information

Global Clinical Lead

Results disclosure agreements