Trial Outcomes & Findings for Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid (NCT NCT00295646)
NCT ID: NCT00295646
Last Updated: 2024-03-15
Results Overview
DFS is defined as time from randomization to first occurrence of a local, regional, or distant recurrence, second primary carcinoma (including contralateral breast cancer), or death from any cause
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1803 participants
Primary outcome timeframe
Time from randomization to the analysis data cut-off date when 124 DFS events had occurred. On the analysis data cut-off date, maximum time on study per patient was 102 months.
Results posted on
2024-03-15
Participant Flow
The first patient was randomized June 17, 1999, the last patient was randomized May 17, 2006. Randomization took place in 66 Austrian and 10 German clinical sites. In total, 1.803 patients were enrolled.
Participant milestones
| Measure |
AZ (Arimidex+Zoledronate)
Study Drugs Arimidex (Anastrozole), Zometa (Zoledronate; zoledronic acid)
anastrozole: 1 mg/d
zoledronic acid: 4 mg q6m
goserelin: 3.6 mg goserelin subcutaneously every 28 days
|
TZ (Tamoxifen+Zoledronate)
Study Drugs Nolvadex (Tamoxifen), Zometa (Zoledronate; zoledronic acid)
tamoxifen: 20 mg/d
zoledronic acid: 4 mg q6m
goserelin: 3.6 mg goserelin subcutaneously every 28 days
|
AC (Arimidex Control)
Study Drug Arimidex (Anastrozole)
anastrozole: 1 mg/d
goserelin: 3.6 mg goserelin subcutaneously every 28 days
|
TC (Tamoxifen Control)
Study Drug Nolvadex (Tamoxifen)
tamoxifen: 20 mg/d
goserelin: 3.6 mg goserelin subcutaneously every 28 days
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
450
|
450
|
453
|
450
|
|
Overall Study
COMPLETED
|
415
|
409
|
403
|
405
|
|
Overall Study
NOT COMPLETED
|
35
|
41
|
50
|
45
|
Reasons for withdrawal
| Measure |
AZ (Arimidex+Zoledronate)
Study Drugs Arimidex (Anastrozole), Zometa (Zoledronate; zoledronic acid)
anastrozole: 1 mg/d
zoledronic acid: 4 mg q6m
goserelin: 3.6 mg goserelin subcutaneously every 28 days
|
TZ (Tamoxifen+Zoledronate)
Study Drugs Nolvadex (Tamoxifen), Zometa (Zoledronate; zoledronic acid)
tamoxifen: 20 mg/d
zoledronic acid: 4 mg q6m
goserelin: 3.6 mg goserelin subcutaneously every 28 days
|
AC (Arimidex Control)
Study Drug Arimidex (Anastrozole)
anastrozole: 1 mg/d
goserelin: 3.6 mg goserelin subcutaneously every 28 days
|
TC (Tamoxifen Control)
Study Drug Nolvadex (Tamoxifen)
tamoxifen: 20 mg/d
goserelin: 3.6 mg goserelin subcutaneously every 28 days
|
|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
18
|
20
|
20
|
18
|
|
Overall Study
Withdrawal by Subject
|
8
|
9
|
11
|
14
|
|
Overall Study
Lost to Follow-up
|
0
|
5
|
1
|
5
|
|
Overall Study
Death
|
9
|
7
|
18
|
8
|
Baseline Characteristics
Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid
Baseline characteristics by cohort
| Measure |
AZ (Arimidex+Zoledronate)
n=450 Participants
Study Drugs Arimidex (Anastrozole), Zometa (Zoledronate; zoledronic acid)
anastrozole: 1 mg/d
zoledronic acid: 4 mg q6m
goserelin: 3.6 mg goserelin subcutaneously every 28 days
|
TZ (Tamoxifen+Zoledronate)
n=450 Participants
Study Drugs Nolvadex (Tamoxifen), Zometa (Zoledronate; zoledronic acid)
tamoxifen: 20 mg/d
zoledronic acid: 4 mg q6m
goserelin: 3.6 mg goserelin subcutaneously every 28 days
|
AC (Arimidex Control)
n=453 Participants
Study Drug Arimidex (Anastrozole)
anastrozole: 1 mg/d
goserelin: 3.6 mg goserelin subcutaneously every 28 days
|
TC (Tamoxifen Control)
n=450 Participants
Study Drug Nolvadex (Tamoxifen)
tamoxifen: 20 mg/d
goserelin: 3.6 mg goserelin subcutaneously every 28 days
|
Total
n=1803 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
44 years
n=5 Participants
|
45 years
n=7 Participants
|
44 years
n=5 Participants
|
45 years
n=4 Participants
|
45 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
450 Participants
n=5 Participants
|
450 Participants
n=7 Participants
|
453 Participants
n=5 Participants
|
450 Participants
n=4 Participants
|
1803 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
pT-stage
pT1
|
343 Participants
n=5 Participants
|
339 Participants
n=7 Participants
|
352 Participants
n=5 Participants
|
341 Participants
n=4 Participants
|
1375 Participants
n=21 Participants
|
|
pT-stage
pT2/pT3
|
98 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
98 Participants
n=4 Participants
|
386 Participants
n=21 Participants
|
|
pT-stage
Unknown
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
pN-stage
Negative
|
304 Participants
n=5 Participants
|
298 Participants
n=7 Participants
|
304 Participants
n=5 Participants
|
305 Participants
n=4 Participants
|
1211 Participants
n=21 Participants
|
|
pN-stage
Positive
|
137 Participants
n=5 Participants
|
138 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
134 Participants
n=4 Participants
|
550 Participants
n=21 Participants
|
|
pN-stage
Unknown
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Histologic grade
G1/G2
|
341 Participants
n=5 Participants
|
347 Participants
n=7 Participants
|
347 Participants
n=5 Participants
|
346 Participants
n=4 Participants
|
1381 Participants
n=21 Participants
|
|
Histologic grade
G3
|
93 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
85 Participants
n=4 Participants
|
352 Participants
n=21 Participants
|
|
Histologic grade
GX
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Histologic grade
Unknown
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Estrogen receptor status
Negative
|
17 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
67 Participants
n=21 Participants
|
|
Estrogen receptor status
Positive
|
424 Participants
n=5 Participants
|
416 Participants
n=7 Participants
|
431 Participants
n=5 Participants
|
423 Participants
n=4 Participants
|
1694 Participants
n=21 Participants
|
|
Estrogen receptor status
Unknown
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Progesterone receptor status
Negative
|
36 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
143 Participants
n=21 Participants
|
|
Progesterone receptor status
Positive
|
405 Participants
n=5 Participants
|
404 Participants
n=7 Participants
|
409 Participants
n=5 Participants
|
399 Participants
n=4 Participants
|
1617 Participants
n=21 Participants
|
|
Progesterone receptor status
Unknown
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
|
Preoperative chemotherapy
No
|
386 Participants
n=5 Participants
|
382 Participants
n=7 Participants
|
389 Participants
n=5 Participants
|
379 Participants
n=4 Participants
|
1536 Participants
n=21 Participants
|
|
Preoperative chemotherapy
Yes
|
26 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
97 Participants
n=21 Participants
|
|
Preoperative chemotherapy
Unknown
|
38 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
170 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Time from randomization to the analysis data cut-off date when 124 DFS events had occurred. On the analysis data cut-off date, maximum time on study per patient was 102 months.Population: Intent-to-treat population: All participants assigned to one of the four treatment arms were included in the analysis
DFS is defined as time from randomization to first occurrence of a local, regional, or distant recurrence, second primary carcinoma (including contralateral breast cancer), or death from any cause
Outcome measures
| Measure |
AZ (Arimidex+Zoledronate)
n=450 Participants
Study Drugs Arimidex (Anastrozole), Zometa (Zoledronate; zoledronic acid)
anastrozole: 1 mg/d
zoledronic acid: 4 mg q6m
goserelin: 3.6 mg goserelin subcutaneously every 28 days
|
TZ (Tamoxifen+Zoledronate)
n=450 Participants
Study Drugs Nolvadex (Tamoxifen), Zometa (Zoledronate; zoledronic acid)
tamoxifen: 20 mg/d
zoledronic acid: 4 mg q6m
goserelin: 3.6 mg goserelin subcutaneously every 28 days
|
AC (Arimidex Control)
n=453 Participants
Study Drug Arimidex (Anastrozole)
anastrozole: 1 mg/d
goserelin: 3.6 mg goserelin subcutaneously every 28 days
|
TC (Tamoxifen Control)
n=450 Participants
Study Drug Nolvadex (Tamoxifen)
tamoxifen: 20 mg/d
goserelin: 3.6 mg goserelin subcutaneously every 28 days
|
|---|---|---|---|---|
|
Comparison of Anastrozole vs Tamoxifen in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Disease-free Survival (DFS)
|
NA years
Not applicable, estimates cannot be calculated due to too few events.
|
NA years
Not applicable, estimates cannot be calculated due to too few events.
|
NA years
Not applicable, estimates cannot be calculated due to too few events.
|
NA years
Not applicable, estimates cannot be calculated due to too few events.
|
PRIMARY outcome
Timeframe: Time from randomization to the analysis data cut-off date when 124 DFS events had occurred. On the analysis data cut-off date, maximum time on study per patient was 102 months.Population: Intent-to-treat population: All participants assigned to one of the four treatment arms were included in the analysis
DFS is defined as time from randomization to first occurrence of a local, regional, or distant recurrence, second primary carcinoma (including contralateral breast cancer), or death from any cause
Outcome measures
| Measure |
AZ (Arimidex+Zoledronate)
n=450 Participants
Study Drugs Arimidex (Anastrozole), Zometa (Zoledronate; zoledronic acid)
anastrozole: 1 mg/d
zoledronic acid: 4 mg q6m
goserelin: 3.6 mg goserelin subcutaneously every 28 days
|
TZ (Tamoxifen+Zoledronate)
n=450 Participants
Study Drugs Nolvadex (Tamoxifen), Zometa (Zoledronate; zoledronic acid)
tamoxifen: 20 mg/d
zoledronic acid: 4 mg q6m
goserelin: 3.6 mg goserelin subcutaneously every 28 days
|
AC (Arimidex Control)
n=453 Participants
Study Drug Arimidex (Anastrozole)
anastrozole: 1 mg/d
goserelin: 3.6 mg goserelin subcutaneously every 28 days
|
TC (Tamoxifen Control)
n=450 Participants
Study Drug Nolvadex (Tamoxifen)
tamoxifen: 20 mg/d
goserelin: 3.6 mg goserelin subcutaneously every 28 days
|
|---|---|---|---|---|
|
Comparison of Zoledronate vs no Zoledronate in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Disease-free Survival (DFS)
|
NA years
Not applicable, estimates cannot be calculated due to too few events.
|
NA years
Not applicable, estimates cannot be calculated due to too few events.
|
NA years
Not applicable, estimates cannot be calculated due to too few events.
|
NA years
Not applicable, estimates cannot be calculated due to too few events.
|
SECONDARY outcome
Timeframe: Time from randomization to the analysis data cut-off date when 124 DFS events had occurred. On the analysis data cut-off date, maximum time on study per patient was 102 months.Population: Intent-to-treat population: All participants assigned to one of the four treatment arms were included in the analysis
RFS is defined as time from randomization to first occurrence of a local, regional, or distant recurrence, second primary carcinoma (including contralateral breast cancer), or death from breast cancer
Outcome measures
| Measure |
AZ (Arimidex+Zoledronate)
n=450 Participants
Study Drugs Arimidex (Anastrozole), Zometa (Zoledronate; zoledronic acid)
anastrozole: 1 mg/d
zoledronic acid: 4 mg q6m
goserelin: 3.6 mg goserelin subcutaneously every 28 days
|
TZ (Tamoxifen+Zoledronate)
n=450 Participants
Study Drugs Nolvadex (Tamoxifen), Zometa (Zoledronate; zoledronic acid)
tamoxifen: 20 mg/d
zoledronic acid: 4 mg q6m
goserelin: 3.6 mg goserelin subcutaneously every 28 days
|
AC (Arimidex Control)
n=453 Participants
Study Drug Arimidex (Anastrozole)
anastrozole: 1 mg/d
goserelin: 3.6 mg goserelin subcutaneously every 28 days
|
TC (Tamoxifen Control)
n=450 Participants
Study Drug Nolvadex (Tamoxifen)
tamoxifen: 20 mg/d
goserelin: 3.6 mg goserelin subcutaneously every 28 days
|
|---|---|---|---|---|
|
Comparison of Anastrozole vs Tamoxifen in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Recurrence-free Survival (RFS)
|
NA years
Not applicable, estimates cannot be calculated due to too few events.
|
NA years
Not applicable, estimates cannot be calculated due to too few events.
|
NA years
Not applicable, estimates cannot be calculated due to too few events.
|
NA years
Not applicable, estimates cannot be calculated due to too few events.
|
SECONDARY outcome
Timeframe: Time from randomization to the analysis data cut-off date when 124 DFS events had occurred. On the analysis data cut-off date, maximum time on study per patient was 102 months.Population: Intent-to-treat population: All participants assigned to one of the four treatment arms were included in the analysis
RFS is defined as time from randomization to first occurrence of a local, regional, or distant recurrence, second primary carcinoma (including contralateral breast cancer), or death from breast cancer
Outcome measures
| Measure |
AZ (Arimidex+Zoledronate)
n=450 Participants
Study Drugs Arimidex (Anastrozole), Zometa (Zoledronate; zoledronic acid)
anastrozole: 1 mg/d
zoledronic acid: 4 mg q6m
goserelin: 3.6 mg goserelin subcutaneously every 28 days
|
TZ (Tamoxifen+Zoledronate)
n=450 Participants
Study Drugs Nolvadex (Tamoxifen), Zometa (Zoledronate; zoledronic acid)
tamoxifen: 20 mg/d
zoledronic acid: 4 mg q6m
goserelin: 3.6 mg goserelin subcutaneously every 28 days
|
AC (Arimidex Control)
n=453 Participants
Study Drug Arimidex (Anastrozole)
anastrozole: 1 mg/d
goserelin: 3.6 mg goserelin subcutaneously every 28 days
|
TC (Tamoxifen Control)
n=450 Participants
Study Drug Nolvadex (Tamoxifen)
tamoxifen: 20 mg/d
goserelin: 3.6 mg goserelin subcutaneously every 28 days
|
|---|---|---|---|---|
|
Comparison of Zoledronate vs no Zoledronate in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Recurrence-free Survival (RFS)
|
NA years
Not applicable, estimates cannot be calculated due to too few events.
|
NA years
Not applicable, estimates cannot be calculated due to too few events.
|
NA years
Not applicable, estimates cannot be calculated due to too few events.
|
NA years
Not applicable, estimates cannot be calculated due to too few events.
|
SECONDARY outcome
Timeframe: Time from randomization to the analysis data cut-off date when 124 DFS events had occurred. On the analysis data cut-off date, maximum time on study per patient was 102 months.Population: Intent-to-treat population: All participants assigned to one of the four treatment arms were included in the analysis
OS is defined as time from randomization to death from any cause
Outcome measures
| Measure |
AZ (Arimidex+Zoledronate)
n=450 Participants
Study Drugs Arimidex (Anastrozole), Zometa (Zoledronate; zoledronic acid)
anastrozole: 1 mg/d
zoledronic acid: 4 mg q6m
goserelin: 3.6 mg goserelin subcutaneously every 28 days
|
TZ (Tamoxifen+Zoledronate)
n=450 Participants
Study Drugs Nolvadex (Tamoxifen), Zometa (Zoledronate; zoledronic acid)
tamoxifen: 20 mg/d
zoledronic acid: 4 mg q6m
goserelin: 3.6 mg goserelin subcutaneously every 28 days
|
AC (Arimidex Control)
n=453 Participants
Study Drug Arimidex (Anastrozole)
anastrozole: 1 mg/d
goserelin: 3.6 mg goserelin subcutaneously every 28 days
|
TC (Tamoxifen Control)
n=450 Participants
Study Drug Nolvadex (Tamoxifen)
tamoxifen: 20 mg/d
goserelin: 3.6 mg goserelin subcutaneously every 28 days
|
|---|---|---|---|---|
|
Comparison of Anastrozole vs Tamoxifen in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Overall Survival (OS)
|
NA years
Not applicable, estimates cannot be calculated due to too few events.
|
NA years
Not applicable, estimates cannot be calculated due to too few events.
|
NA years
Not applicable, estimates cannot be calculated due to too few events.
|
NA years
Not applicable, estimates cannot be calculated due to too few events.
|
SECONDARY outcome
Timeframe: Time from randomization to the analysis data cut-off date when 124 DFS events had occurred. On the analysis data cut-off date, maximum time on study per patient was 102 months.Population: Intent-to-treat population: All participants assigned to one of the four treatment arms were included in the analysis.
OS is defined as time from randomization to death from any cause
Outcome measures
| Measure |
AZ (Arimidex+Zoledronate)
n=450 Participants
Study Drugs Arimidex (Anastrozole), Zometa (Zoledronate; zoledronic acid)
anastrozole: 1 mg/d
zoledronic acid: 4 mg q6m
goserelin: 3.6 mg goserelin subcutaneously every 28 days
|
TZ (Tamoxifen+Zoledronate)
n=450 Participants
Study Drugs Nolvadex (Tamoxifen), Zometa (Zoledronate; zoledronic acid)
tamoxifen: 20 mg/d
zoledronic acid: 4 mg q6m
goserelin: 3.6 mg goserelin subcutaneously every 28 days
|
AC (Arimidex Control)
n=453 Participants
Study Drug Arimidex (Anastrozole)
anastrozole: 1 mg/d
goserelin: 3.6 mg goserelin subcutaneously every 28 days
|
TC (Tamoxifen Control)
n=450 Participants
Study Drug Nolvadex (Tamoxifen)
tamoxifen: 20 mg/d
goserelin: 3.6 mg goserelin subcutaneously every 28 days
|
|---|---|---|---|---|
|
Comparison of Zoledronate vs no Zoledronate in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Overall Survival (OS)
|
NA years
Not applicable, estimates cannot be calculated due to too few events.
|
NA years
Not applicable, estimates cannot be calculated due to too few events.
|
NA years
Not applicable, estimates cannot be calculated due to too few events.
|
NA years
Not applicable, estimates cannot be calculated due to too few events.
|
Adverse Events
AZ (Arimidex+Zoledronate)
Serious events: 67 serious events
Other events: 355 other events
Deaths: 9 deaths
TZ (Tamoxifen+Zoledronate)
Serious events: 103 serious events
Other events: 320 other events
Deaths: 7 deaths
AC (Arimidex Control)
Serious events: 55 serious events
Other events: 340 other events
Deaths: 18 deaths
TC (Tamoxifen Control)
Serious events: 93 serious events
Other events: 290 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
AZ (Arimidex+Zoledronate)
n=450 participants at risk
Study Drugs Arimidex (Anastrozole), Zometa (Zoledronate; zoledronic acid)
anastrozole: 1 mg/d
zoledronic acid: 4 mg q6m
goserelin: 3.6 mg goserelin subcutaneously every 28 days
|
TZ (Tamoxifen+Zoledronate)
n=450 participants at risk
Study Drugs Nolvadex (Tamoxifen), Zometa (Zoledronate; zoledronic acid)
tamoxifen: 20 mg/d
zoledronic acid: 4 mg q6m
goserelin: 3.6 mg goserelin subcutaneously every 28 days
|
AC (Arimidex Control)
n=453 participants at risk
Study Drug Arimidex (Anastrozole)
anastrozole: 1 mg/d
goserelin: 3.6 mg goserelin subcutaneously every 28 days
|
TC (Tamoxifen Control)
n=450 participants at risk
Study Drug Nolvadex (Tamoxifen)
tamoxifen: 20 mg/d
goserelin: 3.6 mg goserelin subcutaneously every 28 days
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.22%
1/450 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.22%
1/450 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/453 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.22%
1/450 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/453 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Reproductive system and breast disorders
Breast inflammation
|
0.22%
1/450 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.22%
1/453 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.67%
3/450 • Number of events 3 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Nervous system disorders
Cognitive disorder
|
0.22%
1/450 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/453 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Skin and subcutaneous tissue disorders
Cutaneous reaction
|
0.67%
3/450 • Number of events 4 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
1.1%
5/450 • Number of events 6 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.22%
1/453 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.67%
3/450 • Number of events 3 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
0.22%
1/450 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.22%
1/453 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.22%
1/450 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Hepatobiliary disorders
Disease of liver / gallbladder
|
0.44%
2/450 • Number of events 2 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.67%
3/450 • Number of events 4 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.44%
2/453 • Number of events 2 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
1.1%
5/450 • Number of events 6 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Nervous system disorders
Dizziness
|
0.22%
1/450 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/453 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.22%
1/450 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
General disorders
Fever
|
0.44%
2/450 • Number of events 2 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.22%
1/450 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.22%
1/453 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.22%
1/450 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Injury, poisoning and procedural complications
Fracture
|
1.6%
7/450 • Number of events 8 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.89%
4/450 • Number of events 4 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.88%
4/453 • Number of events 4 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
1.3%
6/450 • Number of events 6 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Nervous system disorders
Headache
|
0.22%
1/450 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/453 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.22%
1/450 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.22%
1/453 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.22%
1/450 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Nervous system disorders
Hypertonia
|
0.67%
3/450 • Number of events 3 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.22%
1/453 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.44%
2/450 • Number of events 2 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.22%
1/453 • Number of events 2 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Nervous system disorders
Insult / TIA
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.22%
1/453 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.22%
1/450 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Reproductive system and breast disorders
Irregular vaginal discharge
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.22%
1/453 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/453 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.22%
1/450 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Lung inflammation
|
0.44%
2/450 • Number of events 2 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
1.1%
5/450 • Number of events 5 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
1.1%
5/453 • Number of events 5 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
1.3%
6/450 • Number of events 6 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Vascular disorders
Lymphedema (arm, hand)
|
0.22%
1/450 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.22%
1/450 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.44%
2/453 • Number of events 2 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.22%
1/450 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanoma
|
0.22%
1/450 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/453 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.22%
1/450 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Gastrointestinal disorders
Obstipation
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.22%
1/453 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Other tumors
|
0.67%
3/450 • Number of events 3 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.44%
2/450 • Number of events 2 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.44%
2/453 • Number of events 2 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.67%
3/450 • Number of events 3 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Reproductive system and breast disorders
Ovarian changes
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/453 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.44%
2/450 • Number of events 2 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Gastrointestinal disorders
Periodontal disease
|
0.22%
1/450 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.22%
1/450 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/453 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Nervous system disorders
Peripheral nerve disease
|
2.2%
10/450 • Number of events 13 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.22%
1/450 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.88%
4/453 • Number of events 5 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.89%
4/450 • Number of events 5 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Psychiatric disorders
Psychological disorder NOS
|
0.22%
1/450 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.67%
3/450 • Number of events 6 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/453 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.22%
1/450 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Nervous system disorders
Sensory disturbance
|
0.44%
2/450 • Number of events 2 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.44%
2/450 • Number of events 2 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.44%
2/453 • Number of events 3 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Skin and subcutaneous tissue disorders
Skin disease
|
1.1%
5/450 • Number of events 5 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
1.8%
8/450 • Number of events 9 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.66%
3/453 • Number of events 4 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
1.8%
8/450 • Number of events 8 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Musculoskeletal and connective tissue disorders
Spinal troubles/pain
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.22%
1/453 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Gastrointestinal disorders
Stomach pain
|
0.44%
2/450 • Number of events 2 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.67%
3/450 • Number of events 3 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.44%
2/453 • Number of events 2 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.22%
1/450 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Cardiac disorders
Tachycardia
|
0.22%
1/450 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.22%
1/453 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.22%
1/450 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.67%
3/450 • Number of events 5 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
1.1%
5/450 • Number of events 6 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.66%
3/453 • Number of events 5 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.44%
2/450 • Number of events 2 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
1.1%
5/450 • Number of events 5 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/453 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.67%
3/450 • Number of events 3 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Endocrine disorders
Thyroid disease
|
0.44%
2/450 • Number of events 3 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.66%
3/453 • Number of events 3 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.67%
3/450 • Number of events 3 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Ear and labyrinth disorders
Tinnitus/hearing loss
|
0.22%
1/450 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.22%
1/450 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/453 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.22%
1/450 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Injury, poisoning and procedural complications
Torn ligament/Meniscus lesion
|
0.44%
2/450 • Number of events 2 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.22%
1/450 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.44%
2/453 • Number of events 2 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.67%
3/450 • Number of events 4 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Infections and infestations
Uro-genital tract infection
|
1.8%
8/450 • Number of events 9 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
1.6%
7/450 • Number of events 7 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.88%
4/453 • Number of events 4 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
1.3%
6/450 • Number of events 7 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Reproductive system and breast disorders
Uterine polyp
|
1.1%
5/450 • Number of events 6 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
11.6%
52/450 • Number of events 57 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
1.5%
7/453 • Number of events 7 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
8.7%
39/450 • Number of events 45 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Reproductive system and breast disorders
Vaginal bleeding
|
0.67%
3/450 • Number of events 3 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
2.9%
13/450 • Number of events 14 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
1.5%
7/453 • Number of events 7 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
1.3%
6/450 • Number of events 6 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
0.22%
1/450 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.22%
1/450 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/453 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
Other adverse events
| Measure |
AZ (Arimidex+Zoledronate)
n=450 participants at risk
Study Drugs Arimidex (Anastrozole), Zometa (Zoledronate; zoledronic acid)
anastrozole: 1 mg/d
zoledronic acid: 4 mg q6m
goserelin: 3.6 mg goserelin subcutaneously every 28 days
|
TZ (Tamoxifen+Zoledronate)
n=450 participants at risk
Study Drugs Nolvadex (Tamoxifen), Zometa (Zoledronate; zoledronic acid)
tamoxifen: 20 mg/d
zoledronic acid: 4 mg q6m
goserelin: 3.6 mg goserelin subcutaneously every 28 days
|
AC (Arimidex Control)
n=453 participants at risk
Study Drug Arimidex (Anastrozole)
anastrozole: 1 mg/d
goserelin: 3.6 mg goserelin subcutaneously every 28 days
|
TC (Tamoxifen Control)
n=450 participants at risk
Study Drug Nolvadex (Tamoxifen)
tamoxifen: 20 mg/d
goserelin: 3.6 mg goserelin subcutaneously every 28 days
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
150/450 • Number of events 464 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
14.4%
65/450 • Number of events 133 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
24.7%
112/453 • Number of events 315 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
11.6%
52/450 • Number of events 124 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
41.1%
185/450 • Number of events 571 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
29.3%
132/450 • Number of events 332 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
28.3%
128/453 • Number of events 439 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
20.9%
94/450 • Number of events 274 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Reproductive system and breast disorders
Breast inflammation
|
0.22%
1/450 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.22%
1/453 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Nervous system disorders
Cognitive disorder
|
2.0%
9/450 • Number of events 16 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.89%
4/450 • Number of events 6 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.66%
3/453 • Number of events 11 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Skin and subcutaneous tissue disorders
Cutaneous reaction
|
3.3%
15/450 • Number of events 19 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
1.1%
5/450 • Number of events 7 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
4.0%
18/453 • Number of events 30 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
4.2%
19/450 • Number of events 28 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
2.7%
12/450 • Number of events 17 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
3.8%
17/450 • Number of events 21 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
2.4%
11/453 • Number of events 13 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
2.2%
10/450 • Number of events 13 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Nervous system disorders
Dizziness
|
4.0%
18/450 • Number of events 29 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
2.0%
9/450 • Number of events 14 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
1.5%
7/453 • Number of events 12 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
2.9%
13/450 • Number of events 19 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
General disorders
Fatigue
|
21.8%
98/450 • Number of events 262 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
18.2%
82/450 • Number of events 179 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
20.5%
93/453 • Number of events 258 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
15.6%
70/450 • Number of events 156 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
General disorders
Fever
|
10.2%
46/450 • Number of events 51 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
7.6%
34/450 • Number of events 38 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
2.4%
11/453 • Number of events 13 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
2.0%
9/450 • Number of events 11 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.22%
1/450 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.22%
1/453 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.22%
1/450 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Skin and subcutaneous tissue disorders
Hair loss
|
2.0%
9/450 • Number of events 16 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
1.8%
8/450 • Number of events 12 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
1.3%
6/453 • Number of events 8 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
1.3%
6/450 • Number of events 11 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Nervous system disorders
Headache
|
18.9%
85/450 • Number of events 231 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
13.1%
59/450 • Number of events 117 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
13.9%
63/453 • Number of events 163 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
13.1%
59/450 • Number of events 155 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.44%
2/450 • Number of events 2 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.22%
1/453 • Number of events 2 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Vascular disorders
Hot flushes
|
5.6%
25/450 • Number of events 45 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
6.0%
27/450 • Number of events 50 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
5.5%
25/453 • Number of events 56 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
6.2%
28/450 • Number of events 43 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.22%
1/450 • Number of events 10 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.22%
1/453 • Number of events 3 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Nervous system disorders
Hypertonia
|
5.6%
25/450 • Number of events 63 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
4.4%
20/450 • Number of events 36 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
4.4%
20/453 • Number of events 73 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
3.1%
14/450 • Number of events 29 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.22%
1/450 • Number of events 3 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.67%
3/450 • Number of events 6 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/453 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Eye disorders
Impaired vision
|
6.4%
29/450 • Number of events 60 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
6.0%
27/450 • Number of events 58 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
4.9%
22/453 • Number of events 35 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
8.0%
36/450 • Number of events 84 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.44%
2/450 • Number of events 3 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.22%
1/453 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Infections and infestations
Infection of ear, nose, or throat
|
1.1%
5/450 • Number of events 9 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
1.8%
8/450 • Number of events 15 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
1.1%
5/453 • Number of events 6 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
1.6%
7/450 • Number of events 12 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Reproductive system and breast disorders
Irregular vaginal discharge
|
0.44%
2/450 • Number of events 6 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.44%
2/450 • Number of events 2 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.44%
2/453 • Number of events 3 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.67%
3/450 • Number of events 10 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
General disorders
Leg edema
|
0.44%
2/450 • Number of events 4 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
2.2%
10/450 • Number of events 15 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.44%
2/453 • Number of events 4 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
2.0%
9/450 • Number of events 17 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.22%
1/450 • Number of events 3 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.22%
1/453 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Lung inflammation
|
4.9%
22/450 • Number of events 32 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
2.0%
9/450 • Number of events 12 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
2.6%
12/453 • Number of events 14 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
2.9%
13/450 • Number of events 21 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Vascular disorders
Lymphedema (arm, hand)
|
5.8%
26/450 • Number of events 48 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
6.9%
31/450 • Number of events 63 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
6.2%
28/453 • Number of events 131 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
6.4%
29/450 • Number of events 64 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Musculoskeletal and connective tissue disorders
Morning stiffness
|
7.8%
35/450 • Number of events 72 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
3.1%
14/450 • Number of events 20 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
7.3%
33/453 • Number of events 90 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
2.4%
11/450 • Number of events 19 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
0.89%
4/450 • Number of events 5 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
1.8%
8/450 • Number of events 18 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.44%
2/453 • Number of events 2 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
2.0%
9/450 • Number of events 15 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.3%
6/450 • Number of events 7 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
1.6%
7/450 • Number of events 17 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
1.3%
6/453 • Number of events 10 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
1.1%
5/450 • Number of events 6 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Gastrointestinal disorders
Nausea and vomiting
|
10.7%
48/450 • Number of events 88 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
6.4%
29/450 • Number of events 45 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
7.1%
32/453 • Number of events 56 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
5.1%
23/450 • Number of events 41 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Gastrointestinal disorders
Obstipation
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
1.1%
5/450 • Number of events 11 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.22%
1/453 • Number of events 2 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
1.1%
5/450 • Number of events 7 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
General disorders
Other/minor (not categorized)
|
26.4%
119/450 • Number of events 252 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
24.9%
112/450 • Number of events 219 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
23.6%
107/453 • Number of events 224 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
24.0%
108/450 • Number of events 212 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Reproductive system and breast disorders
Ovarian changes
|
0.44%
2/450 • Number of events 2 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.22%
1/453 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.22%
1/450 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Gastrointestinal disorders
Periodontal disease*
|
1.3%
6/450 • Number of events 11 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.67%
3/450 • Number of events 6 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/453 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
1.1%
5/450 • Number of events 7 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Nervous system disorders
Peripheral nerve disease
|
6.4%
29/450 • Number of events 57 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
4.9%
22/450 • Number of events 36 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
3.1%
14/453 • Number of events 31 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
3.8%
17/450 • Number of events 30 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Psychiatric disorders
Psychological disorder NOS
|
17.8%
80/450 • Number of events 205 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
16.4%
74/450 • Number of events 197 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
21.4%
97/453 • Number of events 221 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
15.6%
70/450 • Number of events 174 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Nervous system disorders
Sensory disturbance
|
0.67%
3/450 • Number of events 5 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.22%
1/453 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.44%
2/450 • Number of events 4 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Skin and subcutaneous tissue disorders
Skin disease
|
5.8%
26/450 • Number of events 41 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
7.1%
32/450 • Number of events 68 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
3.5%
16/453 • Number of events 21 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
5.1%
23/450 • Number of events 32 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Musculoskeletal and connective tissue disorders
Spinal troubles/pain
|
3.6%
16/450 • Number of events 26 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
3.3%
15/450 • Number of events 30 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
3.3%
15/453 • Number of events 28 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
2.9%
13/450 • Number of events 26 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Gastrointestinal disorders
Stomach pain
|
3.8%
17/450 • Number of events 27 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
1.8%
8/450 • Number of events 13 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
2.9%
13/453 • Number of events 17 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
1.8%
8/450 • Number of events 12 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Cardiac disorders
Tachycardia
|
2.2%
10/450 • Number of events 16 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
2.0%
9/450 • Number of events 14 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
1.1%
5/453 • Number of events 7 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.44%
2/450 • Number of events 2 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.89%
4/450 • Number of events 7 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.22%
1/450 • Number of events 2 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.88%
4/453 • Number of events 13 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.67%
3/450 • Number of events 5 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Vascular disorders
Thrombosis
|
0.22%
1/450 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/453 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Endocrine disorders
Thyroid disease
|
1.1%
5/450 • Number of events 5 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.44%
2/453 • Number of events 2 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.44%
2/450 • Number of events 2 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Ear and labyrinth disorders
Tinnitus/hearing loss
|
0.89%
4/450 • Number of events 5 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.22%
1/450 • Number of events 5 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.66%
3/453 • Number of events 3 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.44%
2/450 • Number of events 3 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Injury, poisoning and procedural complications
Torn ligament/Meniscus lesion
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.22%
1/453 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.22%
1/450 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Infections and infestations
Uro-genital tract infection
|
0.22%
1/450 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
1.6%
7/450 • Number of events 13 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/453 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.67%
3/450 • Number of events 3 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.22%
1/450 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.22%
1/450 • Number of events 2 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.22%
1/453 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
1.1%
5/450 • Number of events 7 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Reproductive system and breast disorders
Vaginal bleeding
|
1.1%
5/450 • Number of events 6 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.89%
4/450 • Number of events 4 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.44%
2/453 • Number of events 3 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
1.1%
5/450 • Number of events 5 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.22%
1/450 • Number of events 1 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.67%
3/450 • Number of events 12 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.44%
2/453 • Number of events 4 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.00%
0/450 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Reproductive system and breast disorders
Vaginal dryness
|
0.44%
2/450 • Number of events 5 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.44%
2/450 • Number of events 3 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.88%
4/453 • Number of events 10 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.44%
2/450 • Number of events 3 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
0.44%
2/450 • Number of events 4 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.89%
4/450 • Number of events 7 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
0.88%
4/453 • Number of events 5 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
1.8%
8/450 • Number of events 9 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
|
Investigations
Weight gain
|
0.89%
4/450 • Number of events 7 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
1.6%
7/450 • Number of events 11 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
1.8%
8/453 • Number of events 12 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
1.6%
7/450 • Number of events 13 • Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
|
Additional Information
Trial Office Director
ABCSG (Austrian Breast & Colorectal Cancer Study Group)
Phone: +43 1 4089230
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place