Trial Outcomes & Findings for Secondary Adjuvant Long Term Study With Arimidex (NCT NCT00295620)

NCT ID: NCT00295620

Last Updated: 2019-10-02

Results Overview

To determine whether 5 years of additional Anastrozole was more effective than 2 years of additional Anastrozole after 5 years of adjuvant endocrine therapy in terms of disease-free survival.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 3484 participants
• Primary outcome timeframe: DFS was defined as the time from two years after randomization to the earliest occurrence of loco-regional recurrence, distant recurrence, contralateral new breast cancer, second cancer or death from any cause, assessed up to a maximum of 8.5 years
• Results posted on: 2019-10-02

Participant Flow

The first patient was randomized Feb 26, 2004, the last patient was randomized June 30, 2010. Randomization took place in 75 Austrian clinical sites. In total, 3,484 patients were enrolled.

Fourteen patients did not sign the Informed Consent, resulting in 3,470 patients who started the trial.

Participant milestones

Measure	Arm A: Anastrozol 1 mg per day for 2 years	Arm B: Anastrozol 1 mg per day for 5 years
Overall Study STARTED	1732	1738
Overall Study Safety Analysis Set	1705	1710
Overall Study COMPLETED	860	842
Overall Study NOT COMPLETED	872	896

Reasons for withdrawal

Measure	Arm A: Anastrozol 1 mg per day for 2 years	Arm B: Anastrozol 1 mg per day for 5 years
Overall Study Lost to Follow-up	9	5
Overall Study Withdrawal by Subject	37	50
Overall Study Death	206	207
Overall Study Other reasons	10	9
Overall Study Discontinuation by sponsor	580	593
Overall Study Protocol Violation	30	32

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Arm A: Anastrozol n=1732 Participants 1 mg per day for 2 years	Arm B: Anastrozol n=1738 Participants 1 mg per day for 5 years	Total n=3470 Participants Total of all reporting groups
Age, Continuous	65 years n=1732 Participants	64 years n=1738 Participants	64 years n=3470 Participants
Sex: Female, Male Female	1732 Participants n=1732 Participants	1738 Participants n=1738 Participants	3470 Participants n=3470 Participants
Sex: Female, Male Male	0 Participants n=1732 Participants	0 Participants n=1738 Participants	0 Participants n=3470 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
pN-stage pN0	1140 Participants n=1732 Participants	1162 Participants n=1738 Participants	2302 Participants n=3470 Participants
pN-stage pN1	551 Participants n=1732 Participants	523 Participants n=1738 Participants	1074 Participants n=3470 Participants
pN-stage pN2	30 Participants n=1732 Participants	41 Participants n=1738 Participants	71 Participants n=3470 Participants
pN-stage pN3	7 Participants n=1732 Participants	8 Participants n=1738 Participants	15 Participants n=3470 Participants
pN-stage Unknown	4 Participants n=1732 Participants	4 Participants n=1738 Participants	8 Participants n=3470 Participants
pT-stage pT1	1254 Participants n=1732 Participants	1254 Participants n=1738 Participants	2508 Participants n=3470 Participants
pT-stage pT2	440 Participants n=1732 Participants	442 Participants n=1738 Participants	882 Participants n=3470 Participants
pT-stage pT3	30 Participants n=1732 Participants	32 Participants n=1738 Participants	62 Participants n=3470 Participants
pT-stage pTx	4 Participants n=1732 Participants	6 Participants n=1738 Participants	10 Participants n=3470 Participants
pT-stage Unknown	4 Participants n=1732 Participants	4 Participants n=1738 Participants	8 Participants n=3470 Participants
Previous Chemotherapy Chemotherapy containing anthracycline	246 Participants n=1732 Participants	236 Participants n=1738 Participants	482 Participants n=3470 Participants
Previous Chemotherapy Chemotherapy containing taxane	93 Participants n=1732 Participants	95 Participants n=1738 Participants	188 Participants n=3470 Participants
Previous Chemotherapy Other chemotherapy	167 Participants n=1732 Participants	163 Participants n=1738 Participants	330 Participants n=3470 Participants
Previous Chemotherapy No chemotherapy	1224 Participants n=1732 Participants	1241 Participants n=1738 Participants	2465 Participants n=3470 Participants
Previous Chemotherapy Unknown	2 Participants n=1732 Participants	3 Participants n=1738 Participants	5 Participants n=3470 Participants
Previous Endocrine Therapy 2 years of anti-estrogen + 3 years Anastrozole	416 Participants n=1732 Participants	419 Participants n=1738 Participants	835 Participants n=3470 Participants
Previous Endocrine Therapy 5 years of anti-estrogen	855 Participants n=1732 Participants	862 Participants n=1738 Participants	1717 Participants n=3470 Participants
Previous Endocrine Therapy Another, comparable endocrine therapy	459 Participants n=1732 Participants	454 Participants n=1738 Participants	913 Participants n=3470 Participants
Previous Endocrine Therapy Unknown	2 Participants n=1732 Participants	3 Participants n=1738 Participants	5 Participants n=3470 Participants
Estrogen Receptor Status Negative	45 Participants n=1732 Participants	46 Participants n=1738 Participants	91 Participants n=3470 Participants
Estrogen Receptor Status Positive (+/++/+++)	1686 Participants n=1732 Participants	1689 Participants n=1738 Participants	3375 Participants n=3470 Participants
Estrogen Receptor Status Unknown	1 Participants n=1732 Participants	3 Participants n=1738 Participants	4 Participants n=3470 Participants
Progesterone Receptor Status Negative	332 Participants n=1732 Participants	356 Participants n=1738 Participants	688 Participants n=3470 Participants
Progesterone Receptor Status Positive (+/++/+++)	1398 Participants n=1732 Participants	1375 Participants n=1738 Participants	2773 Participants n=3470 Participants
Progesterone Receptor Status Unknown	2 Participants n=1732 Participants	7 Participants n=1738 Participants	9 Participants n=3470 Participants
Surgery Type Breast-conserving surgery	1360 Participants n=1732 Participants	1405 Participants n=1738 Participants	2765 Participants n=3470 Participants
Surgery Type Modified radical mastectomy	367 Participants n=1732 Participants	319 Participants n=1738 Participants	686 Participants n=3470 Participants
Surgery Type Other	4 Participants n=1732 Participants	12 Participants n=1738 Participants	16 Participants n=3470 Participants
Surgery Type Unknown	1 Participants n=1732 Participants	2 Participants n=1738 Participants	3 Participants n=3470 Participants
Sentinel Node Biopsy No	900 Participants n=1732 Participants	887 Participants n=1738 Participants	1787 Participants n=3470 Participants
Sentinel Node Biopsy Yes	820 Participants n=1732 Participants	836 Participants n=1738 Participants	1656 Participants n=3470 Participants
Sentinel Node Biopsy Unknown	12 Participants n=1732 Participants	15 Participants n=1738 Participants	27 Participants n=3470 Participants
Axillary Surgery No	386 Participants n=1732 Participants	405 Participants n=1738 Participants	791 Participants n=3470 Participants
Axillary Surgery Yes	1345 Participants n=1732 Participants	1331 Participants n=1738 Participants	2676 Participants n=3470 Participants
Axillary Surgery Unknown	1 Participants n=1732 Participants	2 Participants n=1738 Participants	3 Participants n=3470 Participants
Tumor Grading G1	247 Participants n=1732 Participants	261 Participants n=1738 Participants	508 Participants n=3470 Participants
Tumor Grading G2	1107 Participants n=1732 Participants	1090 Participants n=1738 Participants	2197 Participants n=3470 Participants
Tumor Grading G3	326 Participants n=1732 Participants	348 Participants n=1738 Participants	674 Participants n=3470 Participants
Tumor Grading GX	27 Participants n=1732 Participants	12 Participants n=1738 Participants	39 Participants n=3470 Participants
Tumor Grading Unknown	25 Participants n=1732 Participants	27 Participants n=1738 Participants	52 Participants n=3470 Participants
Previous Radiotherapy No	356 Participants n=1732 Participants	327 Participants n=1738 Participants	683 Participants n=3470 Participants
Previous Radiotherapy Yes	1373 Participants n=1732 Participants	1407 Participants n=1738 Participants	2780 Participants n=3470 Participants
Previous Radiotherapy Unknown	3 Participants n=1732 Participants	4 Participants n=1738 Participants	7 Participants n=3470 Participants

PRIMARY outcome

Timeframe: DFS was defined as the time from two years after randomization to the earliest occurrence of loco-regional recurrence, distant recurrence, contralateral new breast cancer, second cancer or death from any cause, assessed up to a maximum of 8.5 years

Population: Per-Protocol (PP) Population, defined as all randomized patients who signed the informed consent who complied with the inclusion and exclusion criteria, who had at least one follow-up examination after randomization and who survived without recurrence for two years.

To determine whether 5 years of additional Anastrozole was more effective than 2 years of additional Anastrozole after 5 years of adjuvant endocrine therapy in terms of disease-free survival.

Outcome measures

Measure	Arm A: Anastrozol n=1281 Participants 1 mg per day for 2 years	Arm B: Anastrozol n=1323 Participants 1 mg per day for 5 years
Disease-free Survival After Prolonged Endocrine Treatment	NA Years Interval 7.7 to NA - Not applicable, estimates cannot be calculated due to too few events.	NA Years Interval 8.1 to NA - Not applicable, estimates cannot be calculated due to too few events.

SECONDARY outcome

Timeframe: Overall survival was defined as the time from two years after randomization to death due to any cause, assessed up to a maximum of 8.5 years

Population: All randomized patients who signed the informed consent and who did not die during two first two years

To determine whether 5 years of additional Anastrozole was more effective than 2 years of additional Anastrozole after 5 years of adjuvant endocrine therapy in terms of overall survival.

Outcome measures

Measure	Arm A: Anastrozol n=1665 Participants 1 mg per day for 2 years	Arm B: Anastrozol n=1670 Participants 1 mg per day for 5 years
Overall Survival After Prolonged Endocrine Treatment	NA Years NA - Not applicable, estimates cannot be calculated due to too few events.	NA Years NA - Not applicable, estimates cannot be calculated due to too few events.

SECONDARY outcome

Timeframe: Time to first clinical fracture was defined as time to first clinical fracture, in the period from 2 years until 5 years after randomization for each patient.

Population: All randomized patients who signed the informed consent and who had no fractures during the first two years

To determine the effect of 2 years versus 5 years of additional Anastrozole after 5 years of adjuvant endocrine therapy on the time to first clinical fracture. Patients without clinical fractures where censored at their last therapy visit (approximately 5 years after randomization).

Outcome measures

Measure	Arm A: Anastrozol n=1555 Participants 1 mg per day for 2 years	Arm B: Anastrozol n=1570 Participants 1 mg per day for 5 years
Time to First Clinical Fracture	NA Years NA - Not applicable, estimates cannot be calculated due to too few events.	NA Years NA - Not applicable, estimates cannot be calculated due to too few events.

SECONDARY outcome

Timeframe: Risk of secondary carcinoma was defined as the time from two years after randomization to first occurrence of new secondary cancer without new breast cancer (local or contralateral), assessed up to a maximum of 8.5 years

Population: All randomized patients who signed the informed consent and had no secondary carcinoma (excluding contralateral mammacarcinoma) during the first two years

To determine whether 5 years of additional Anastrozole was more effective than 2 years of additional Anastrozole after 5 years of adjuvant endocrine therapy in terms of lowering the risk of secondary carcinoma. Subjects without secondary cancer event were censored at the last date when they were known to be secondary cancer free.

Outcome measures

Measure	Arm A: Anastrozol n=1620 Participants 1 mg per day for 2 years	Arm B: Anastrozol n=1620 Participants 1 mg per day for 5 years
Time to Secondary Carcinoma	NA Years NA - Not applicable, estimates cannot be calculated due to too few events.	NA Years NA - Not applicable, estimates cannot be calculated due to too few events.

SECONDARY outcome

Timeframe: Risk of contralateral breast cancer was defined as the time from two years after randomization to first occurrence of new contralateral breast cancer, assessed up to a maximum of 8.5 years

Population: All randomized patients who signed the informed consent and had no contralateral mammacarcinoma during the first two years

To determine whether 5 years of additional Anastrozole was more effective than 2 years of additional Anastrozole after 5 years of adjuvant endocrine therapy in terms of lowering the risk of contralateral breast cancer. Subjects without contralateral breast cancer event were censored at the last date when they were known to be contralateral breast cancer free.

Outcome measures

Measure	Arm A: Anastrozol n=1636 Participants 1 mg per day for 2 years	Arm B: Anastrozol n=1641 Participants 1 mg per day for 5 years
Time to Contralateral Breast Cancer	NA Years NA - Not applicable, estimates cannot be calculated due to too few events.	NA Years NA - Not applicable, estimates cannot be calculated due to too few events.

Adverse Events

Arm B: Anastrozol - 1 mg Per Day for 5 Years

Serious events: 687 serious events

Other events: 0 other events

Deaths: 207 deaths

Arm A: Anastrozol - 1 mg Per Day for 2 Years

Serious events: 452 serious events

Other events: 0 other events

Deaths: 207 deaths

Serious adverse events

Measure	Arm B: Anastrozol - 1 mg Per Day for 5 Years n=1710 participants at risk Description (Arm-group)	Arm A: Anastrozol - 1 mg Per Day for 2 Years n=1705 participants at risk Description (Arm-group)
Blood and lymphatic system disorders Anaemia	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Blood and lymphatic system disorders Anaemia macrocytic	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Blood and lymphatic system disorders Bone marrow oedema	0.18% 3/1710 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Blood and lymphatic system disorders Haemolytic anaemia	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Blood and lymphatic system disorders Immune thrombocytopenic purpura	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Blood and lymphatic system disorders Leukopenia	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Blood and lymphatic system disorders Lymph node calcification	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Blood and lymphatic system disorders Lymphadenitis	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Blood and lymphatic system disorders Lymphadenopathy	0.18% 3/1710 • Number of events 6 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Blood and lymphatic system disorders Mastocytosis	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Blood and lymphatic system disorders Spontaneous haematoma	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Cardiac disorders Acute myocardial infarction	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Cardiac disorders Angina pectoris	0.23% 4/1710 • Number of events 6 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.23% 4/1705 • Number of events 9 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Cardiac disorders Aortic valve disease	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Cardiac disorders Aortic valve prolapse	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Cardiac disorders Aortic valve stenosis	0.12% 2/1710 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Cardiac disorders Arrhythmia	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Cardiac disorders Arteriosclerosis coronary artery	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Cardiac disorders Atrial fibrillation	0.99% 17/1710 • Number of events 37 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.35% 6/1705 • Number of events 10 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Cardiac disorders Atrial flutter	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Cardiac disorders Atrial tachycardia	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Cardiac disorders Atrioventricular block	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Cardiac disorders Atrioventricular block complete	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Cardiac disorders Bradycardia	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Cardiac disorders Cardiac arrest	0.06% 1/1710 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Cardiac disorders Cardiac disorder	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Cardiac disorders Cardiac failure	0.41% 7/1710 • Number of events 15 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.35% 6/1705 • Number of events 12 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Cardiac disorders Cardiac flutter	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Cardiac disorders Cardiomyopathy	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Cardiac disorders Cardiopulmonary failure	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Cardiac disorders Congestive cardiomyopathy	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Cardiac disorders Cor pulmonale chronic	0.06% 1/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Cardiac disorders Coronary artery disease	0.47% 8/1710 • Number of events 17 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.35% 6/1705 • Number of events 13 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Cardiac disorders Intracardiac thrombus	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Cardiac disorders Ischaemic cardiomyopathy	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Cardiac disorders Mitral valve disease	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Cardiac disorders Mitral valve disease mixed	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Cardiac disorders Mitral valve incompetence	0.23% 4/1710 • Number of events 7 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Cardiac disorders Myocardial infarction	0.23% 4/1710 • Number of events 8 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Cardiac disorders Myocardial ischaemia	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Cardiac disorders Palpitations	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Cardiac disorders Pulmonary valve incompetence	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Cardiac disorders Right ventricular failure	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Cardiac disorders Sinus node dysfunction	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Cardiac disorders Sinus tachycardia	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Cardiac disorders Supraventricular tachycardia	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Cardiac disorders Tachycardia	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.18% 3/1705 • Number of events 9 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Cardiac disorders Tachycardia paroxysmal	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Cardiac disorders Tricuspid valve incompetence	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Cardiac disorders Ventricular extrasystoles	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Cardiac disorders Ventricular tachycardia	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Cardiac disorders Wolff-parkinson-white syndrome	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Congenital, familial and genetic disorders Adenomatous polyposis coli	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Congenital, familial and genetic disorders Anomalous arrangement of pancreaticobiliary duct	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Congenital, familial and genetic disorders Choledochal cyst	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Congenital, familial and genetic disorders Congenital uterine anomaly	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Congenital, familial and genetic disorders Corneal opacity congenital	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Congenital, familial and genetic disorders Developmental hip dysplasia	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Congenital, familial and genetic disorders Epidermal naevus	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Congenital, familial and genetic disorders Foramen magnum stenosis	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Ear and labyrinth disorders Cupulolithiasis	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Ear and labyrinth disorders Deafness	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Ear and labyrinth disorders Deafness unilateral	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Ear and labyrinth disorders Inner ear disorder	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Ear and labyrinth disorders Meniere's disease	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Ear and labyrinth disorders Tinnitus	0.12% 2/1710 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Ear and labyrinth disorders Tympanosclerosis	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Ear and labyrinth disorders Vertigo	0.47% 8/1710 • Number of events 15 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.29% 5/1705 • Number of events 9 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Ear and labyrinth disorders Vertigo positional	0.12% 2/1710 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Endocrine disorders Goitre	0.70% 12/1710 • Number of events 22 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.23% 4/1705 • Number of events 8 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Endocrine disorders Hyperparathyroidism	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Endocrine disorders Hyperparathyroidism primary	0.12% 2/1710 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Endocrine disorders Hyperthyroidism	0.18% 3/1710 • Number of events 6 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Endocrine disorders Thyroid haemorrhage	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Endocrine disorders Thyroid mass	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Eye disorders Age-related macular degeneration	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Eye disorders Astigmatism	0.06% 1/1710 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Eye disorders Blepharochalasis	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Eye disorders Cataract	1.5% 26/1710 • Number of events 68 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.70% 12/1705 • Number of events 26 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Eye disorders Cataract cortical	0.23% 4/1710 • Number of events 10 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Eye disorders Cataract nuclear	0.12% 2/1710 • Number of events 5 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Eye disorders Dacryostenosis acquired	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Eye disorders Exfoliation syndrome	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Eye disorders Eye haemorrhage	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Eye disorders Glaucoma	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Eye disorders Lens dislocation	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Eye disorders Macular degeneration	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Eye disorders Macular hole	0.18% 3/1710 • Number of events 6 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Eye disorders Maculopathy	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Eye disorders Myopia	0.06% 1/1710 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Eye disorders Photopsia	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Eye disorders Retinal artery occlusion	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Eye disorders Retinal degeneration	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Eye disorders Retinal detachment	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Eye disorders Retinal disorder	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Eye disorders Retinal haemorrhage	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Eye disorders Retinal tear	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Eye disorders Retinopathy hypertensive	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Eye disorders Vitreous haemorrhage	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Abdominal discomfort	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Abdominal hernia	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Abdominal pain	0.76% 13/1710 • Number of events 22 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.23% 4/1705 • Number of events 12 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Abdominal pain lower	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Abdominal pain upper	0.18% 3/1710 • Number of events 7 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 5 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Abdominal symptom	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Abdominal wall disorder	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Abnormal faeces	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Acute abdomen	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Anal haemorrhage	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Anal incontinence	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Anal polyp	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Anorectal discomfort	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Anorectal disorder	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Ascites	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Chronic gastritis	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Coeliac disease	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Colitis	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Colitis ischaemic	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Colitis microscopic	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Colitis ulcerative	0.12% 2/1710 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Constipation	0.23% 4/1710 • Number of events 7 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Dental alveolar anomaly	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Diarrhoea	0.70% 12/1710 • Number of events 21 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.35% 6/1705 • Number of events 11 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Diarrhoea haemorrhagic	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Diverticular perforation	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Diverticulum	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Diverticulum intestinal	0.35% 6/1710 • Number of events 12 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Duodenitis	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Dyspepsia	0.12% 2/1710 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Dysphagia	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Enteritis	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Enterocele	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Erosive duodenitis	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Gastric polyps	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Gastric ulcer	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Gastritis	0.18% 3/1710 • Number of events 5 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.29% 5/1705 • Number of events 10 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Gastritis erosive	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Gastrointestinal disorder	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.29% 5/1710 • Number of events 10 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.18% 3/1705 • Number of events 6 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Haematochezia	0.12% 2/1710 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.23% 4/1705 • Number of events 7 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Haemorrhoids	0.29% 5/1710 • Number of events 10 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Hiatus hernia	0.18% 3/1710 • Number of events 5 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Ileus	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Inflammatory bowel disease	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Inguinal hernia	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Intestinal fistula	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Intestinal polyp	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Intestinal prolapse	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Large intestine perforation	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Large intestine polyp	0.94% 16/1710 • Number of events 28 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.47% 8/1705 • Number of events 17 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Mallory-weiss syndrome	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Mechanical ileus	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Mouth haemorrhage	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Nausea	0.41% 7/1710 • Number of events 13 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.23% 4/1705 • Number of events 14 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Oesophagitis	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Pancreatic cyst	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Pancreatitis	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Pancreatitis acute	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Pancreatitis necrotising	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Proctitis	0.12% 2/1710 • Number of events 6 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Rectal polyp	0.29% 5/1710 • Number of events 10 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Subileus	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Tooth disorder	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Umbilical hernia	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Gastrointestinal disorders Vomiting	0.23% 4/1710 • Number of events 8 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.18% 3/1705 • Number of events 10 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
General disorders Asthenia	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
General disorders Calcinosis	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
General disorders Chest discomfort	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
General disorders Chest pain	0.53% 9/1710 • Number of events 19 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.23% 4/1705 • Number of events 6 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
General disorders Condition aggravated	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
General disorders Death	0.35% 6/1710 • Number of events 12 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
General disorders Fat necrosis	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
General disorders Fatigue	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
General disorders Fibrosis	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
General disorders General physical health deterioration	0.06% 1/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.23% 4/1705 • Number of events 7 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
General disorders Hernia	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
General disorders Hyperplasia	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
General disorders Ill-defined disorder	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
General disorders Impaired healing	0.23% 4/1710 • Number of events 8 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
General disorders Implant site extravasation	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
General disorders Implant site fibrosis	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
General disorders Incarcerated hernia	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
General disorders Inflammation	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
General disorders Multiple organ dysfunction syndrome	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
General disorders Oedema mucosal	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
General disorders Pain	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
General disorders Peripheral swelling	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
General disorders Polyp	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
General disorders Pyrexia	0.23% 4/1710 • Number of events 8 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
General disorders Sudden cardiac death	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Hepatobiliary disorders Ampulla of vater stenosis	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Hepatobiliary disorders Bile duct stenosis	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Hepatobiliary disorders Bile duct stone	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Hepatobiliary disorders Biliary tract disorder	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Hepatobiliary disorders Cholecystitis	0.18% 3/1710 • Number of events 6 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Hepatobiliary disorders Cholecystitis acute	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Hepatobiliary disorders Cholecystitis chronic	0.23% 4/1710 • Number of events 5 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Hepatobiliary disorders Cholelithiasis	0.82% 14/1710 • Number of events 27 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.88% 15/1705 • Number of events 27 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Hepatobiliary disorders Gallbladder disorder	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Hepatobiliary disorders Hepatic cyst	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Hepatobiliary disorders Hepatic steatosis	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Hepatobiliary disorders Hepatitis cholestatic	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Hepatobiliary disorders Jaundice	0.06% 1/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Hepatobiliary disorders Non-alcoholic steatohepatitis	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Immune system disorders Allergy to arthropod bite	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Infections and infestations Abdominal abscess	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Infections and infestations Abdominal wall abscess	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Infections and infestations Abscess of salivary gland	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Infections and infestations Acute sinusitis	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Infections and infestations Appendicitis	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Infections and infestations Bronchitis	0.18% 3/1710 • Number of events 5 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.18% 3/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Infections and infestations Campylobacter gastroenteritis	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Infections and infestations Chest wall abscess	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Infections and infestations Conjunctivitis	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Infections and infestations Diverticulitis	0.29% 5/1710 • Number of events 13 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.41% 7/1705 • Number of events 16 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Infections and infestations Diverticulitis intestinal haemorrhagic	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Infections and infestations Ear infection	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Infections and infestations Encephalitis	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Infections and infestations Erysipelas	0.35% 6/1710 • Number of events 13 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.41% 7/1705 • Number of events 10 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Infections and infestations Extradural abscess	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Infections and infestations Fungal infection	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Infections and infestations Gastroenteritis	0.23% 4/1710 • Number of events 7 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.18% 3/1705 • Number of events 6 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Infections and infestations Helicobacter gastritis	0.18% 3/1710 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Infections and infestations Herpes zoster	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Infections and infestations Infected dermal cyst	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Infections and infestations Intervertebral discitis	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Infections and infestations Meningitis viral	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Infections and infestations Nasopharyngitis	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Infections and infestations Neuroborreliosis	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Infections and infestations Osteomyelitis acute	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Infections and infestations Peritonitis	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Infections and infestations Pharyngitis	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Infections and infestations Pneumonia	0.64% 11/1710 • Number of events 22 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.29% 5/1705 • Number of events 12 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Infections and infestations Pyelonephritis	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Infections and infestations Pyometra	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Infections and infestations Respiratory tract infection	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 5 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Infections and infestations Rhinitis	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Infections and infestations Salpingitis	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Infections and infestations Sepsis	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Infections and infestations Sinobronchitis	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Infections and infestations Sinusitis	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Infections and infestations Skin infection	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Infections and infestations Subcutaneous abscess	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Infections and infestations Tonsillitis	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Infections and infestations Urethral carbuncle	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Infections and infestations Urinary tract infection	0.64% 11/1710 • Number of events 23 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Infections and infestations Urosepsis	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Infections and infestations Vaginal infection	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Infections and infestations Vestibular neuronitis	0.12% 2/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Infections and infestations Vulval abscess	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Acetabulum fracture	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Anaemia postoperative	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Ankle fracture	1.2% 20/1710 • Number of events 38 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.29% 5/1705 • Number of events 9 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Bankart lesion	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Bone contusion	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Clavicle fracture	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Compression fracture	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Concussion	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.18% 3/1705 • Number of events 6 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Contusion	0.58% 10/1710 • Number of events 18 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.23% 4/1705 • Number of events 10 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Coronary bypass thrombosis	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Facial bones fracture	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Fall	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Femoral neck fracture	0.29% 5/1710 • Number of events 9 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Femur fracture	0.47% 8/1710 • Number of events 12 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.18% 3/1705 • Number of events 6 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Fibula fracture	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Foot fracture	0.23% 4/1710 • Number of events 8 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.41% 7/1705 • Number of events 14 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Forearm fracture	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.18% 3/1705 • Number of events 5 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Fracture	0.18% 3/1710 • Number of events 5 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.18% 3/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Fractured sacrum	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Hand fracture	0.35% 6/1710 • Number of events 12 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Head injury	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Hip fracture	0.18% 3/1710 • Number of events 5 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Humerus fracture	0.76% 13/1710 • Number of events 24 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.29% 5/1705 • Number of events 8 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Ilium fracture	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Incisional hernia	0.35% 6/1710 • Number of events 10 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Incisional hernia, obstructive	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Injury	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Intentional overdose	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Intestinal anastomosis complication	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Joint dislocation	0.12% 2/1710 • Number of events 6 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Keratorhexis	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Laceration	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Ligament injury	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Ligament rupture	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Ligament sprain	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Limb injury	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Lower limb fracture	0.12% 2/1710 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.18% 3/1710 • Number of events 6 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.29% 5/1705 • Number of events 11 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Meniscus injury	0.82% 14/1710 • Number of events 27 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.23% 4/1705 • Number of events 8 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Multiple fractures	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Multiple injuries	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Muscle injury	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Neck injury	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Overdose	0.06% 1/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Patella fracture	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Pelvic fracture	0.12% 2/1710 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Post procedural complication	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Postoperative wound complication	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Pubis fracture	0.23% 4/1710 • Number of events 7 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Radiation oesophagitis	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Radius fracture	1.7% 29/1710 • Number of events 55 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	1.2% 21/1705 • Number of events 40 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Rib fracture	0.18% 3/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.23% 4/1705 • Number of events 6 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Road traffic accident	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Scapula fracture	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Skin abrasion	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Skin injury	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Spinal compression fracture	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Spinal fracture	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Splenic rupture	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Stress fracture	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Subarachnoid haemorrhage	0.18% 3/1710 • Number of events 6 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Subdural haemorrhage	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Suture related complication	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Tendon rupture	0.23% 4/1710 • Number of events 6 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.18% 3/1710 • Number of events 6 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.18% 3/1705 • Number of events 5 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Tibia fracture	0.29% 5/1710 • Number of events 8 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.18% 3/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Traumatic fracture	0.06% 1/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Traumatic haematoma	0.12% 2/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Traumatic lung injury	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Ulna fracture	0.18% 3/1710 • Number of events 5 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Upper limb fracture	0.29% 5/1710 • Number of events 8 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.23% 4/1705 • Number of events 7 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Injury, poisoning and procedural complications Wrist fracture	0.23% 4/1710 • Number of events 7 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Investigations Angiogram	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Investigations Biopsy lymph gland	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Investigations Blood creatinine increased	0.12% 2/1710 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Investigations Blood glucose abnormal	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Investigations Blood pressure increased	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Investigations Bronchoscopy	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Investigations Carcinoembryonic antigen increased	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Investigations Colonoscopy	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Investigations Electrocardiogram change	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Investigations Endoscopic retrograde cholangiopancreatography	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Investigations Endoscopy upper gastrointestinal tract	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Investigations Lipids abnormal	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Investigations Liver function test increased	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Investigations Occult blood positive	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Investigations Platelet count decreased	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Investigations Smear cervix abnormal	0.06% 1/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Investigations Tumour marker increased	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Investigations Varicella virus test positive	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Investigations Weight decreased	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Metabolism and nutrition disorders Calciphylaxis	0.06% 1/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Metabolism and nutrition disorders Dehydration	0.12% 2/1710 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Metabolism and nutrition disorders Diabetes mellitus	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.12% 2/1710 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Metabolism and nutrition disorders Glucose tolerance impaired	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Metabolism and nutrition disorders Hyperglycaemia	0.18% 3/1710 • Number of events 6 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Metabolism and nutrition disorders Hyperkalaemia	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Metabolism and nutrition disorders Hypokalaemia	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Metabolism and nutrition disorders Hyponatraemia	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Metabolism and nutrition disorders Obesity	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Musculoskeletal and connective tissue disorders Arthralgia	0.41% 7/1710 • Number of events 10 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Musculoskeletal and connective tissue disorders Arthritis	0.12% 2/1710 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Musculoskeletal and connective tissue disorders Arthrofibrosis	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Musculoskeletal and connective tissue disorders Arthropathy	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Musculoskeletal and connective tissue disorders Back pain	0.41% 7/1710 • Number of events 13 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.18% 3/1705 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Musculoskeletal and connective tissue disorders Bone pain	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Musculoskeletal and connective tissue disorders Bursitis	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.18% 3/1705 • Number of events 6 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Musculoskeletal and connective tissue disorders Chondropathy	0.06% 1/1710 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Musculoskeletal and connective tissue disorders Exostosis	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Musculoskeletal and connective tissue disorders Foot deformity	0.82% 14/1710 • Number of events 28 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.82% 14/1705 • Number of events 30 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.88% 15/1710 • Number of events 29 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.53% 9/1705 • Number of events 15 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.18% 3/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Musculoskeletal and connective tissue disorders Joint stiffness	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.18% 3/1710 • Number of events 6 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.18% 3/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Musculoskeletal and connective tissue disorders Muscular weakness	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Musculoskeletal and connective tissue disorders Musculoskeletal disorder	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Musculoskeletal and connective tissue disorders Myopathy	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Musculoskeletal and connective tissue disorders Myosclerosis	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Musculoskeletal and connective tissue disorders Neck pain	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Musculoskeletal and connective tissue disorders Osteoarthritis	4.3% 74/1710 • Number of events 164 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	1.7% 29/1705 • Number of events 60 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Musculoskeletal and connective tissue disorders Osteochondrosis	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Musculoskeletal and connective tissue disorders Osteoporosis	0.23% 4/1710 • Number of events 8 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.18% 3/1705 • Number of events 8 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Musculoskeletal and connective tissue disorders Osteoporotic fracture	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Musculoskeletal and connective tissue disorders Pain in extremity	0.23% 4/1710 • Number of events 7 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.18% 3/1705 • Number of events 7 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Musculoskeletal and connective tissue disorders Plica syndrome	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Musculoskeletal and connective tissue disorders Polyarthritis	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Musculoskeletal and connective tissue disorders Rheumatic disorder	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.29% 5/1705 • Number of events 9 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Musculoskeletal and connective tissue disorders Spinal deformity	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Musculoskeletal and connective tissue disorders Spinal fusion acquired	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.18% 3/1710 • Number of events 5 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 6 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.29% 5/1710 • Number of events 10 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Musculoskeletal and connective tissue disorders Synovitis	0.18% 3/1710 • Number of events 6 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Musculoskeletal and connective tissue disorders Tendon pain	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Musculoskeletal and connective tissue disorders Tendonitis	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Musculoskeletal and connective tissue disorders Tenosynovitis	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.18% 3/1705 • Number of events 6 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Musculoskeletal and connective tissue disorders Tenosynovitis stenosans	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Musculoskeletal and connective tissue disorders Trigger finger	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Musculoskeletal and connective tissue disorders Vertebral foraminal stenosis	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.23% 4/1710 • Number of events 6 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma pancreas	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenoma benign	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adrenal adenoma	0.12% 2/1710 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Angiomyolipoma	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Angiosarcoma	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.12% 2/1710 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell small lymphocytic lymphoma	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.47% 8/1710 • Number of events 19 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign breast neoplasm	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.23% 4/1710 • Number of events 6 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder papilloma	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's disease	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast angiosarcoma	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.76% 13/1710 • Number of events 22 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer female	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer in situ	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer metastatic	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer recurrent	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast neoplasm	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial carcinoma	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoid tumour of the caecum	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoid tumour of the stomach	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cardiac neoplasm unspecified	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholesteatoma	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic myeloid leukaemia	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell renal cell carcinoma	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.18% 3/1705 • Number of events 5 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.18% 3/1710 • Number of events 8 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.23% 4/1705 • Number of events 7 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large b-cell lymphoma stage i	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Enchondromatosis	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial adenocarcinoma	0.12% 2/1710 • Number of events 6 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Essential thrombocythaemia	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fallopian tube cancer	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fallopian tube cancer metastatic	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibroma	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gallbladder cancer	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric neoplasm	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma multiforme	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glomus tumour	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma of breast	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intra-abdominal haemangioma	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal proliferative breast lesion	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive breast carcinoma	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive lobular breast carcinoma	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leiomyoma	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.18% 3/1705 • Number of events 6 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.35% 6/1710 • Number of events 12 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.18% 3/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma stage iv	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of uterine adnexa	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant peritoneal neoplasm	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningeal neoplasm	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mesothelioma malignant	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to abdominal cavity	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to breast	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.12% 2/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lymph nodes	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastasis	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic bronchial carcinoma	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mucinous breast carcinoma	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm skin	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine tumour	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-hodgkin's lymphoma	0.12% 2/1710 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oral fibroma	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Osteochondroma	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian adenoma	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.18% 3/1705 • Number of events 5 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Parathyroid tumour benign	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenocarcinoma	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenoma	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rosai-dorfman syndrome	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sarcoma uterus	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small intestine adenocarcinoma	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.23% 4/1710 • Number of events 6 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the cervix	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Superficial spreading melanoma stage ii	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Superficial spreading melanoma stage unspecified	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid adenoma	0.18% 3/1710 • Number of events 5 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tongue neoplasm benign	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.35% 6/1710 • Number of events 15 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Nervous system disorders Ataxia	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Nervous system disorders Autonomic nervous system imbalance	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Nervous system disorders Brain stem infarction	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Nervous system disorders Burning feet syndrome	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Nervous system disorders Carotid artery aneurysm	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Nervous system disorders Carotid artery stenosis	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Nervous system disorders Carpal tunnel syndrome	0.58% 10/1710 • Number of events 18 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.59% 10/1705 • Number of events 23 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Nervous system disorders Cerebral haemorrhage	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Nervous system disorders Cerebral infarction	0.18% 3/1710 • Number of events 5 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 5 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Nervous system disorders Cerebral ischaemia	0.12% 2/1710 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Nervous system disorders Cerebrovascular accident	0.29% 5/1710 • Number of events 12 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Nervous system disorders Cervical radiculopathy	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Nervous system disorders Cervicobrachial syndrome	0.23% 4/1710 • Number of events 8 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Nervous system disorders Dementia	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Nervous system disorders Dizziness	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 7 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Nervous system disorders Dysaesthesia	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Nervous system disorders Embolic cerebral infarction	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Nervous system disorders Epilepsy	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Nervous system disorders Facial paralysis	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Nervous system disorders Generalised tonic-clonic seizure	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Nervous system disorders Haemorrhage intracranial	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Nervous system disorders Headache	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Nervous system disorders Hemiparesis	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Nervous system disorders Horner's syndrome	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Nervous system disorders Hypertonia	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Nervous system disorders Hypoaesthesia	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Nervous system disorders Intracranial aneurysm	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Nervous system disorders Ischaemic cerebral infarction	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Nervous system disorders Lumbar radiculopathy	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Nervous system disorders Memory impairment	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Nervous system disorders Mental impairment	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Nervous system disorders Myelopathy	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Nervous system disorders Nerve root compression	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Nervous system disorders Neuromuscular blockade	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Nervous system disorders Paraesthesia	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Nervous system disorders Paralysis	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Nervous system disorders Parkinson's disease	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Nervous system disorders Partial seizures	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Nervous system disorders Peroneal nerve palsy	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.18% 3/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Nervous system disorders Polyneuropathy	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Nervous system disorders Quadriparesis	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Nervous system disorders Radicular pain	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Nervous system disorders Ruptured cerebral aneurysm	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Nervous system disorders Sciatica	0.58% 10/1710 • Number of events 20 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.53% 9/1705 • Number of events 17 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Nervous system disorders Speech disorder	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Nervous system disorders Spinal cord compression	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Nervous system disorders Syncope	0.53% 9/1710 • Number of events 17 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.18% 3/1705 • Number of events 5 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Nervous system disorders Tension headache	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Nervous system disorders Thalamic infarction	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Nervous system disorders Transient ischaemic attack	0.47% 8/1710 • Number of events 15 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Nervous system disorders Trigeminal neuralgia	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Nervous system disorders Vertigo cns origin	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Nervous system disorders Visual pathway disorder	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Nervous system disorders Vocal cord paresis	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Product Issues Device breakage	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Psychiatric disorders Adjustment disorder with depressed mood	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 6 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Psychiatric disorders Anxiety disorder	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Psychiatric disorders Bipolar disorder	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Psychiatric disorders Burnout syndrome	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Psychiatric disorders Completed suicide	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Psychiatric disorders Depression	0.41% 7/1710 • Number of events 13 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.35% 6/1705 • Number of events 12 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Psychiatric disorders Insomnia	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Psychiatric disorders Intentional self-injury	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Psychiatric disorders Major depression	0.06% 1/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Psychiatric disorders Mental disorder	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Psychiatric disorders Panic attack	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Psychiatric disorders Persistent depressive disorder	0.12% 2/1710 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Psychiatric disorders Schizoaffective disorder	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Psychiatric disorders Schizoaffective disorder depressive type	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 6 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Psychiatric disorders Somatic symptom disorder	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Renal and urinary disorders Acute kidney injury	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Renal and urinary disorders Haematuria	0.18% 3/1710 • Number of events 5 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Renal and urinary disorders Hydronephrosis	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Renal and urinary disorders Micturition disorder	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Renal and urinary disorders Nephrolithiasis	0.12% 2/1710 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.18% 3/1705 • Number of events 6 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Renal and urinary disorders Renal aneurysm	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Renal and urinary disorders Renal artery stenosis	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Renal and urinary disorders Renal colic	0.12% 2/1710 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Renal and urinary disorders Renal cyst	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Renal and urinary disorders Renal failure	0.18% 3/1710 • Number of events 6 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Renal and urinary disorders Renal mass	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Renal and urinary disorders Renal pain	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Renal and urinary disorders Stress urinary incontinence	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Renal and urinary disorders Ureteric stenosis	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Renal and urinary disorders Urethral haemorrhage	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Renal and urinary disorders Urethral stenosis	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Renal and urinary disorders Urinary incontinence	0.23% 4/1710 • Number of events 8 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Renal and urinary disorders Urinary retention	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Reproductive system and breast disorders Adenomyosis	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 6 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Reproductive system and breast disorders Adnexa uteri cyst	0.12% 2/1710 • Number of events 5 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Reproductive system and breast disorders Breast calcifications	0.29% 5/1710 • Number of events 10 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.23% 4/1705 • Number of events 6 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Reproductive system and breast disorders Breast disorder	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Reproductive system and breast disorders Breast fibrosis	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Reproductive system and breast disorders Breast hyperplasia	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Reproductive system and breast disorders Breast mass	0.12% 2/1710 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Reproductive system and breast disorders Breast necrosis	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Reproductive system and breast disorders Cervical dysplasia	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Reproductive system and breast disorders Cervical polyp	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Reproductive system and breast disorders Colpocele	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Reproductive system and breast disorders Cystocele	0.18% 3/1710 • Number of events 6 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Reproductive system and breast disorders Ectropion of cervix	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Reproductive system and breast disorders Endometrial atrophy	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Reproductive system and breast disorders Endometrial disorder	0.23% 4/1710 • Number of events 12 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Reproductive system and breast disorders Endometrial hyperplasia	0.94% 16/1710 • Number of events 39 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.35% 6/1705 • Number of events 16 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Reproductive system and breast disorders Endometrial metaplasia	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Reproductive system and breast disorders Hydrometra	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Reproductive system and breast disorders Menometrorrhagia	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Reproductive system and breast disorders Menorrhagia	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Reproductive system and breast disorders Metrorrhagia	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 6 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Reproductive system and breast disorders Nipple exudate bloody	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Reproductive system and breast disorders Ovarian cyst	0.47% 8/1710 • Number of events 17 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.23% 4/1705 • Number of events 17 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Reproductive system and breast disorders Ovarian disorder	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Reproductive system and breast disorders Pelvic pain	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Reproductive system and breast disorders Postmenopausal haemorrhage	0.64% 11/1710 • Number of events 22 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.53% 9/1705 • Number of events 19 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Reproductive system and breast disorders Rectocele	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.18% 3/1705 • Number of events 6 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Reproductive system and breast disorders Uterine disorder	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Reproductive system and breast disorders Uterine polyp	0.94% 16/1710 • Number of events 51 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.35% 6/1705 • Number of events 17 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Reproductive system and breast disorders Uterine prolapse	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Reproductive system and breast disorders Uterovaginal prolapse	0.29% 5/1710 • Number of events 10 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Reproductive system and breast disorders Vaginal cyst	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Reproductive system and breast disorders Vaginal dysplasia	0.06% 1/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Reproductive system and breast disorders Vaginal haemorrhage	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.41% 7/1705 • Number of events 12 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Reproductive system and breast disorders Vaginal polyp	0.12% 2/1710 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Reproductive system and breast disorders Vaginal prolapse	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Reproductive system and breast disorders Vaginal stricture	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Reproductive system and breast disorders Vulva cyst	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Respiratory, thoracic and mediastinal disorders Bronchial polyp	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.29% 5/1710 • Number of events 11 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.18% 3/1705 • Number of events 6 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Respiratory, thoracic and mediastinal disorders Cough	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.53% 9/1710 • Number of events 17 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.18% 3/1705 • Number of events 5 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.18% 3/1710 • Number of events 5 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Respiratory, thoracic and mediastinal disorders Emphysema	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.23% 4/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Respiratory, thoracic and mediastinal disorders Hyperventilation	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Respiratory, thoracic and mediastinal disorders Hypoventilation	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Respiratory, thoracic and mediastinal disorders Nasal turbinate abnormality	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Respiratory, thoracic and mediastinal disorders Nocturnal dyspnoea	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.18% 3/1710 • Number of events 7 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.12% 2/1710 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Respiratory, thoracic and mediastinal disorders Pulmonary artery thrombosis	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.82% 14/1710 • Number of events 27 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.23% 4/1705 • Number of events 8 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Respiratory, thoracic and mediastinal disorders Pulmonary vascular disorder	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.12% 2/1710 • Number of events 7 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Respiratory, thoracic and mediastinal disorders Sinus disorder	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.12% 2/1710 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Skin and subcutaneous tissue disorders Actinic keratosis	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 12 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Skin and subcutaneous tissue disorders Blister	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 6 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Skin and subcutaneous tissue disorders Dermal cyst	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Skin and subcutaneous tissue disorders Dermatitis	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Skin and subcutaneous tissue disorders Eczema	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Skin and subcutaneous tissue disorders Erythema	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Skin and subcutaneous tissue disorders Excessive granulation tissue	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Skin and subcutaneous tissue disorders Hidradenitis	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Skin and subcutaneous tissue disorders Lichen sclerosus	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Skin and subcutaneous tissue disorders Petechiae	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Skin and subcutaneous tissue disorders Sebaceous gland disorder	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Skin and subcutaneous tissue disorders Skin necrosis	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Skin and subcutaneous tissue disorders Skin ulcer	0.23% 4/1710 • Number of events 7 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Skin and subcutaneous tissue disorders Urticaria chronic	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Alcohol rehabilitation	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Angioplasty	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Aortic valve replacement	0.06% 1/1710 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Arthrodesis	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Breast operation	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Breast reconstruction	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Bunion operation	0.12% 2/1710 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Cancer surgery	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Cardiac pacemaker insertion	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Cardiac pacemaker replacement	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Carpal tunnel decompression	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Cataract operation	0.12% 2/1710 • Number of events 6 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.18% 3/1705 • Number of events 5 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Central venous catheter removal	0.12% 2/1710 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Cholecystectomy	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Colostomy	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Enterostomy	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Eye operation	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Gastric banding	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Hernia repair	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Hip arthroplasty	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.23% 4/1705 • Number of events 6 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Hysterectomy	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Hysterosalpingo-oophorectomy	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Intraocular lens implant	0.12% 2/1710 • Number of events 6 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Jaw operation	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Joint arthroplasty	0.12% 2/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Knee arthroplasty	0.29% 5/1710 • Number of events 10 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.18% 3/1705 • Number of events 6 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Knee operation	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Large intestinal polypectomy	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Lipoma excision	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Lithotripsy	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Lymphadenectomy	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Mammoplasty	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Medical device removal	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Mole excision	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Nasal operation	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Nephrectomy	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Oophorectomy	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Oophorectomy bilateral	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Plastic surgery	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Posterior lens capsulotomy	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Postoperative care	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Radioactive iodine therapy	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Rectal polypectomy	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Renal cyst excision	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Salpingo-oophorectomy bilateral	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Scar excision	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Skin graft	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Spinal decompression	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Spinal operation	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Synovectomy	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Synovial cyst removal	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Tendon operation	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Thyreostatic therapy	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Thyroidectomy	0.12% 2/1710 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Toe operation	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Tooth extraction	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Uterine tumour excision	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Vaginoperineoplasty	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Surgical and medical procedures Varicose vein operation	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Vascular disorders Aortic aneurysm	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Vascular disorders Aortic arteriosclerosis	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Vascular disorders Aortic dissection	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Vascular disorders Aortic stenosis	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Vascular disorders Arteriosclerosis	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Vascular disorders Blood pressure fluctuation	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Vascular disorders Blood pressure inadequately controlled	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Vascular disorders Circulatory collapse	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Vascular disorders Deep vein thrombosis	0.41% 7/1710 • Number of events 15 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.18% 3/1705 • Number of events 5 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Vascular disorders Embolism	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Vascular disorders Embolism arterial	0.06% 1/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Vascular disorders Extrinsic iliac vein compression	0.06% 1/1710 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Vascular disorders Haematoma	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Vascular disorders Hypertension	0.47% 8/1710 • Number of events 14 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.35% 6/1705 • Number of events 10 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Vascular disorders Hypertensive crisis	0.76% 13/1710 • Number of events 27 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Vascular disorders Iliac artery occlusion	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Vascular disorders Intermittent claudication	0.06% 1/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Vascular disorders Lymphoedema	0.18% 3/1710 • Number of events 8 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.12% 2/1705 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Vascular disorders Orthostatic hypotension	0.12% 2/1710 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Vascular disorders Peripheral arterial occlusive disease	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Vascular disorders Peripheral artery occlusion	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Vascular disorders Peripheral artery stenosis	0.12% 2/1710 • Number of events 4 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Vascular disorders Peripheral venous disease	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.23% 4/1705 • Number of events 8 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Vascular disorders Subclavian artery stenosis	0.06% 1/1710 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Vascular disorders Temporal arteritis	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 2 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Vascular disorders Thrombosis	0.18% 3/1710 • Number of events 8 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Vascular disorders Varicose vein	0.47% 8/1710 • Number of events 15 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.70% 12/1705 • Number of events 27 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Vascular disorders Vasculitis	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 3 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Vascular disorders Vein disorder	0.00% 0/1710 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.06% 1/1705 • Number of events 1 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.
Vascular disorders Venous thrombosis	0.23% 4/1710 • Number of events 6 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.	0.00% 0/1705 • Maximum observation period per patient 10.5 years; reporting period for all-cause mortality starts with randomization; adverse event reporting starts with first dose of treatment All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. SAEs are based on the safety population (randomized and received at least one dose of study treatment). Other adverse events were not collected in the safety database and are therefore not reported here.

Other adverse events

Adverse event data not reported

Additional Information

Trial Office Director

ABCSG

Phone: +43 1 4089230

Email: info@abcsg.at

Results disclosure agreements

• Principal investigator is a sponsor employee PI/Sponsor collaborate in good faith regarding contents/formation of any PI publication/disclosure; PI pays due consideration to comments/opinions of Sponsor. Prior to any publication PI undertakes to provide Sponsor with preliminary data and drafts of publication/disclosures (oral or written) and with proposed final manuscript. Sponsor can review within 30 days and can require that submission for publication/disclosure of manuscript be delayed in order for Sponsor to file patent applications.
• Publication restrictions are in place

Restriction type: OTHER