Trial Outcomes & Findings for Real Life Evaluation of Lupron in the Management of Prostate Cancer: A Canadian Post Marketing Observational Study (NCT NCT01386684)

Last Updated: 2018-12-13

Results Overview

PFS defined as the time from patient recruitment to biochemical progression based on doubling of prostate specific antigen (PSA) velocity or PSA \> 5.0, objective tumor progression (RECIST criteria), or death. The distribution of PFS was estimated using Kaplan-Meier methodology. The point estimate and standard error (SE) of the distribution are provided.

Recruitment status

COMPLETED

Target enrollment

552 participants

Primary outcome timeframe

36 months

Results posted on

2018-12-13

Participant Flow

Participant milestones

Participant milestones
Measure	Patients With Prostate Cancer Patients with prostate cancer who were receiving treatment with Lupron.
Overall Study STARTED	552
Overall Study COMPLETED	259
Overall Study NOT COMPLETED	293

Reasons for withdrawal

Reasons for withdrawal
Measure	Patients With Prostate Cancer Patients with prostate cancer who were receiving treatment with Lupron.
Overall Study Lost to Follow-up	51
Overall Study Other	51
Overall Study Death	47
Overall Study Withdrawal of Consent	44
Overall Study Alternative Therapy Required	37
Overall Study Disease Progression	28
Overall Study Adverse Event	20
Overall Study Noncompliance	8
Overall Study Protocol Violation	4
Overall Study Missing	3

Baseline Characteristics

Real Life Evaluation of Lupron in the Management of Prostate Cancer: A Canadian Post Marketing Observational Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients With Prostate Cancer n=552 Participants Patients with prostate cancer who were receiving treatment with Lupron.
Age, Continuous	76.3 years STANDARD_DEVIATION 8.7 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	552 Participants n=5 Participants

PRIMARY outcome

Timeframe: 36 months

Outcome measures

Outcome measures
Measure	Patients With Prostate Cancer n=552 Participants Patients with prostate cancer who were receiving treatment with Lupron.
Progression-free Survival (PFS) Defined as the Time From Patient Recruitment to Biochemical Progression Based on Doubling of Prostate Specific Antigen (PSA) Velocity or PSA > 5.0	20.76 months Standard Error 0.59

PRIMARY outcome

Timeframe: 36 months

A second definition of PFS was used due to changes in the definition of biochemical progression: the time from patient recruitment to a change to an absolute value of PSA \> 2 ng/mL on at least 2 consecutive tests, objective tumor progression (RECIST criteria), or death. The distribution of PFS was estimated using Kaplan-Meier methodology. The point estimate and standard error (SE) of the distribution are provided.

Outcome measures

Outcome measures
Measure	Patients With Prostate Cancer n=552 Participants Patients with prostate cancer who were receiving treatment with Lupron.
Progression-free Survival (PFS) Defined as the Time From Patient Recruitment to a Change to an Absolute Value of PSA > 2 ng/mL on at Least 2 Consecutive Tests	21.89 months Standard Error 0.69

SECONDARY outcome

Timeframe: 36 months

Population: All participants who achieved PSA levels ≤ 2 ng/mL

CRPC defined as PSA \> 2 ng/mL on at least 2 consecutive tests.

Outcome measures

Outcome measures
Measure	Patients With Prostate Cancer n=440 Participants Patients with prostate cancer who were receiving treatment with Lupron.
Castration Resistant Prostate Cancer (CRPC): Number of Participants	84 participants

SECONDARY outcome

Timeframe: 36 months

Population: All participants who achieved PSA levels ≤2 ng/mL

CRPC defined as PSA \> 2 ng/mL on at least 2 consecutive tests. The distribution of time to CRPC was estimated using Kaplan-Meier methodology. The point estimate and standard error of the distribution are provided.

Outcome measures

Outcome measures
Measure	Patients With Prostate Cancer n=440 Participants Patients with prostate cancer who were receiving treatment with Lupron.
Castration Resistant Prostate Cancer (CRPC): Time to Event	26.01 months Standard Error 0.42

SECONDARY outcome

Timeframe: Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36

Population: All participants with available data at given time point.

Total serum testosterone was assessed at each study visit. The percentage of participants with total serum testosterone ≤ 0.7 nmol/L, \> 0.7 to ≤ 1.7 nmol/L, and \> 1.7 nmol/L are provided at each time point.

Outcome measures

Outcome measures
Measure	Patients With Prostate Cancer n=552 Participants Patients with prostate cancer who were receiving treatment with Lupron.
Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit Month 18: ≤ 0.7 nmol/L	69.0 percentage of participants
Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit Month 24: ≤ 0.7 nmol/L	68.8 percentage of participants
Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit Month 0: ≤ 0.7 nmol/L	16.3 percentage of participants
Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit Month 3: ≤ 0.7 nmol/L	65.3 percentage of participants
Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit Month 6: ≤ 0.7 nmol/L	62.9 percentage of participants
Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit Month 12: ≤ 0.7 nmol/L	68.8 percentage of participants
Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit Month 12: > 0.7 to ≤ 1.7 nmol/L	18.8 percentage of participants
Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit Month 18: > 0.7 to ≤ 1.7 nmol/L	15.5 percentage of participants
Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit Month 24: > 0.7 to ≤ 1.7 nmol/L	12.5 percentage of participants
Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit Month 30: > 0.7 to ≤ 1.7 nmol/L	12.8 percentage of participants
Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit Month 36: > 0.7 to ≤ 1.7 nmol/L	15.6 percentage of participants
Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit Month 0: > 1.7 nmol/L	77.4 percentage of participants
Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit Month 3: > 1.7 nmol/L	2.0 percentage of participants
Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit Month 6: > 1.7 nmol/L	5.7 percentage of participants
Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit Month 12: > 1.7 nmol/L	12.5 percentage of participants
Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit Month 18: > 1.7 nmol/L	15.5 percentage of participants
Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit Month 24: > 1.7 nmol/L	18.8 percentage of participants
Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit Month 30: > 1.7 nmol/L	18.0 percentage of participants
Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit Month 36: > 1.7 nmol/L	28.7 percentage of participants
Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit Month 30: ≤ 0.7 nmol/L	69.2 percentage of participants
Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit Month 36: ≤ 0.7 nmol/L	55.7 percentage of participants
Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit Month 0: > 0.7 to ≤ 1.7 nmol/L	6.3 percentage of participants
Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit Month 3: > 0.7 to ≤ 1.7 nmol/L	32.7 percentage of participants
Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit Month 6: > 0.7 to ≤ 1.7 nmol/L	31.4 percentage of participants

SECONDARY outcome

Timeframe: Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36

Population: All participants with available data at given time point.

Total serum testosterone was assessed at each study visit.

Outcome measures

Outcome measures
Measure	Patients With Prostate Cancer n=552 Participants Patients with prostate cancer who were receiving treatment with Lupron.
Total Serum Testosterone Levels at Each Visit Month 0	10.9 nmol/L Standard Deviation 8.90
Total Serum Testosterone Levels at Each Visit Month 3	0.6 nmol/L Standard Deviation 0.98
Total Serum Testosterone Levels at Each Visit Month 6	1.0 nmol/L Standard Deviation 2.32
Total Serum Testosterone Levels at Each Visit Month 12	1.5 nmol/L Standard Deviation 3.29
Total Serum Testosterone Levels at Each Visit Month 18	1.9 nmol/L Standard Deviation 4.05
Total Serum Testosterone Levels at Each Visit Month 24	2.1 nmol/L Standard Deviation 4.31
Total Serum Testosterone Levels at Each Visit Month 30	2.3 nmol/L Standard Deviation 4.81
Total Serum Testosterone Levels at Each Visit Month 36	2.9 nmol/L Standard Deviation 4.69

SECONDARY outcome

Timeframe: 36 months

Population: All participants who achieved castrate testosterone levels (≤1.7 nmol/L)

Total serum testosterone was assessed at each study visit. The time to increased total serum testosterone over the castrate levels (\>1.7 nmol/L) are provided. The distribution of time to increase in total serum testosterone levels was estimated using Kaplan-Meier methodology. The point estimate and standard error (SE) of the distribution are provided.

Outcome measures

Outcome measures
Measure	Patients With Prostate Cancer n=359 Participants Patients with prostate cancer who were receiving treatment with Lupron.
Total Serum Testosterone: Time to Increase Over Castrate Levels	31.20 months Standard Error 0.67

SECONDARY outcome

Timeframe: Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36

Population: All participants with available date at given time point

Serum PSA was assessed at each study visit. The percentage of participants with serum PSA \< 1 ng/mL, 1 to \< 5 ng/mL, 5 to \< 10 ng/mL, and ≥10 ng/mL are provided at each time point.

Outcome measures

Outcome measures
Measure	Patients With Prostate Cancer n=552 Participants Patients with prostate cancer who were receiving treatment with Lupron.
Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit Month 6: <1 ng/mL	61.8 percentage of participants
Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit Month 12: <1 ng/mL	63.6 percentage of participants
Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit Month 0: <1 ng/mL	15.2 percentage of participants
Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit Month 3: <1 ng/mL	55.9 percentage of participants
Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit Month 18: <1 ng/mL	64.6 percentage of participants
Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit Month 24: <1 ng/mL	60.7 percentage of participants
Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit Month 30: <1 ng/mL	56.9 percentage of participants
Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit Month 36: <1 ng/mL	57.5 percentage of participants
Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit Month 0: 1 to <5 ng/mL	17.4 percentage of participants
Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit Month 3: 1 to <5 ng/mL	31.4 percentage of participants
Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit Month 6: 1 to <5 ng/mL	21.5 percentage of participants
Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit Month 12: 1 to <5 ng/mL	16.8 percentage of participants
Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit Month 18: 1 to <5 ng/mL	17.9 percentage of participants
Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit Month 24: 1 to <5 ng/mL	16.4 percentage of participants
Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit Month 30: 1 to <5 ng/mL	19.8 percentage of participants
Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit Month 36: 1 to <5 ng/mL	18.9 percentage of participants
Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit Month 0: 5 to <10 ng/mL	17.6 percentage of participants
Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit Month 3: 5 to <10 ng/mL	4.1 percentage of participants
Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit Month 6: 5 to <10 ng/mL	7.6 percentage of participants
Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit Month 12: 5 to <10 ng/mL	7.5 percentage of participants
Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit Month 18: 5 to <10 ng/mL	8.9 percentage of participants
Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit Month 24: 5 to <10 ng/mL	6.8 percentage of participants
Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit Month 30: 5 to <10 ng/mL	7.5 percentage of participants
Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit Month 36: 5 to <10 ng/mL	9.0 percentage of participants
Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit Month 0: ≥10 ng/mL	49.7 percentage of participants
Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit Month 3: ≥10 ng/mL	8.6 percentage of participants
Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit Month 6: ≥10 ng/mL	9.0 percentage of participants
Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit Month 12: ≥10 ng/mL	12.1 percentage of participants
Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit Month 18: ≥10 ng/mL	8.6 percentage of participants
Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit Month 24: ≥10 ng/mL	16.1 percentage of participants
Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit Month 30: ≥10 ng/mL	15.8 percentage of participants
Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit Month 36: ≥10 ng/mL	14.6 percentage of participants

SECONDARY outcome

Timeframe: Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36

Population: All participants with available data at given time point.

Serum PSA was assessed at each study visit.

Outcome measures

Outcome measures
Measure	Patients With Prostate Cancer n=552 Participants Patients with prostate cancer who were receiving treatment with Lupron.
Prostatic Specific Antigen (PSA) Levels at Each Visit Month 0	65.0 ng/ml Standard Deviation 377.60
Prostatic Specific Antigen (PSA) Levels at Each Visit Month 3	6.5 ng/ml Standard Deviation 41.33
Prostatic Specific Antigen (PSA) Levels at Each Visit Month 6	12.0 ng/ml Standard Deviation 80.64
Prostatic Specific Antigen (PSA) Levels at Each Visit Month 12	19.1 ng/ml Standard Deviation 128.51
Prostatic Specific Antigen (PSA) Levels at Each Visit Month 18	13.3 ng/ml Standard Deviation 113.98
Prostatic Specific Antigen (PSA) Levels at Each Visit Month 24	11.2 ng/ml Standard Deviation 56.69
Prostatic Specific Antigen (PSA) Levels at Each Visit Month 30	13.5 ng/ml Standard Deviation 65.79
Prostatic Specific Antigen (PSA) Levels at Each Visit Month 36	8.2 ng/ml Standard Deviation 37.12

SECONDARY outcome

Timeframe: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

The FACT-G questionnaire is used with patients of any tumor type to assess patient quality of life (QoL). FACT-G is a self-administered, 28-item questionnaire assessing physical, functional, social and emotional well-being, as well as patient satisfaction with treatment. All questions in the FACT-G use a 5-point rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 4 = Very much). The FACT-G total score is computed as the sum of the four subscale scores and has a possible range of 0-108. Higher scores indicate better QoL. Change in FACT-G was analyzed using repeated measures mixed effects general linear model (GLM). A positive change from baseline indicates improved QoL.

Outcome measures

Outcome measures
Measure	Patients With Prostate Cancer n=552 Participants Patients with prostate cancer who were receiving treatment with Lupron.
Functional Assessment of Cancer Therapy Questionnaire - General (FACT-G) Total Score: Change From Baseline to Each Visit Month 3	-0.9 units on a scale Standard Error 0.6
Functional Assessment of Cancer Therapy Questionnaire - General (FACT-G) Total Score: Change From Baseline to Each Visit Month 6	-2.2 units on a scale Standard Error 0.6
Functional Assessment of Cancer Therapy Questionnaire - General (FACT-G) Total Score: Change From Baseline to Each Visit Month 12	-1.7 units on a scale Standard Error 0.6
Functional Assessment of Cancer Therapy Questionnaire - General (FACT-G) Total Score: Change From Baseline to Each Visit Month 18	-1.0 units on a scale Standard Error 0.7
Functional Assessment of Cancer Therapy Questionnaire - General (FACT-G) Total Score: Change From Baseline to Each Visit Month 24	-1.4 units on a scale Standard Error 0.7
Functional Assessment of Cancer Therapy Questionnaire - General (FACT-G) Total Score: Change From Baseline to Each Visit Month 30	-1.3 units on a scale Standard Error 0.7
Functional Assessment of Cancer Therapy Questionnaire - General (FACT-G) Total Score: Change From Baseline to Each Visit Month 36	-1.9 units on a scale Standard Error 0.8

SECONDARY outcome

Timeframe: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

The FACT-P questionnaire is used with patients with prostate cancer to assess patient quality of life (QoL). FACT-P is a self-administered, 28-item questionnaire assessing physical, functional, social and emotional well-being, as well as patient satisfaction with treatment. All questions in the FACT-P use a 5-point rating scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; and 4 = very much). The FACT-P total score is computed as the sum of the four subscale scores and has a possible range of 0-108. Higher scores indicate better QoL. Change in FACT-P was analyzed using repeated measures mixed effects general linear model (GLM). A negative change from baseline indicates decreased QoL.

Outcome measures

Outcome measures
Measure	Patients With Prostate Cancer n=552 Participants Patients with prostate cancer who were receiving treatment with Lupron.
Functional Assessment of Cancer Therapy Questionnaire - Prostate Cancer (FACT-P) Total Score: Change From Baseline to Each Visit Month 3	-1.1 units on a scale Standard Error 0.8
Functional Assessment of Cancer Therapy Questionnaire - Prostate Cancer (FACT-P) Total Score: Change From Baseline to Each Visit Month 6	-2.8 units on a scale Standard Error 0.8
Functional Assessment of Cancer Therapy Questionnaire - Prostate Cancer (FACT-P) Total Score: Change From Baseline to Each Visit Month 12	-2.4 units on a scale Standard Error 0.9
Functional Assessment of Cancer Therapy Questionnaire - Prostate Cancer (FACT-P) Total Score: Change From Baseline to Each Visit Month 18	-1.8 units on a scale Standard Error 0.9
Functional Assessment of Cancer Therapy Questionnaire - Prostate Cancer (FACT-P) Total Score: Change From Baseline to Each Visit Month 24	-2.1 units on a scale Standard Error 0.9
Functional Assessment of Cancer Therapy Questionnaire - Prostate Cancer (FACT-P) Total Score: Change From Baseline to Each Visit Month 30	-2.3 units on a scale Standard Error 1.0
Functional Assessment of Cancer Therapy Questionnaire - Prostate Cancer (FACT-P) Total Score: Change From Baseline to Each Visit Month 36	-3.0 units on a scale Standard Error 1.0

SECONDARY outcome

Timeframe: Month 0 (Baseline) and Months 6, 12, 18, 24, 30, and 36

IIEF-5 is a 5-item, self-administered questionnaire assessing the presence and severity of erectile dysfunction. A score of 1 (very low) to 5 (very high) is awarded to each of the 5 questions. The IIEF-5 total score is a sum of the responses to the 5 items. Total scores range from 5 to 25, with higher scores indicating less dysfunction. Change in IIEF-5 was analyzed using repeated measures mixed effects general linear model (GLM). A negative change from baseline indicates an increase in dysfunction.

Outcome measures

Outcome measures
Measure	Patients With Prostate Cancer n=552 Participants Patients with prostate cancer who were receiving treatment with Lupron.
International Index of Erectile Function (IIEF-5) Total Score: Change From Baseline to Each Visit Month 36	-3.3 units on a scale Standard Error 0.3
International Index of Erectile Function (IIEF-5) Total Score: Change From Baseline to Each Visit Month 6	-2.7 units on a scale Standard Error 0.3
International Index of Erectile Function (IIEF-5) Total Score: Change From Baseline to Each Visit Month 12	-3.2 units on a scale Standard Error 0.3
International Index of Erectile Function (IIEF-5) Total Score: Change From Baseline to Each Visit Month 18	-3.3 units on a scale Standard Error 0.3
International Index of Erectile Function (IIEF-5) Total Score: Change From Baseline to Each Visit Month 24	-3.7 units on a scale Standard Error 0.3
International Index of Erectile Function (IIEF-5) Total Score: Change From Baseline to Each Visit Month 30	-3.5 units on a scale Standard Error 0.3

SECONDARY outcome

Timeframe: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

Population: All participants with available data at given time point.

The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.

Outcome measures

Outcome measures
Measure	Patients With Prostate Cancer n=552 Participants Patients with prostate cancer who were receiving treatment with Lupron.
Health Care Utilization and Health Economics Questionnaire: Number of Participants With Medical Insurance for Prescription Medications Month 0	452 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants With Medical Insurance for Prescription Medications Month 3	408 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants With Medical Insurance for Prescription Medications Month 6	384 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants With Medical Insurance for Prescription Medications Month 12	328 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants With Medical Insurance for Prescription Medications Month 18	279 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants With Medical Insurance for Prescription Medications Month 24	258 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants With Medical Insurance for Prescription Medications Month 30	220 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants With Medical Insurance for Prescription Medications Month 36	196 Participants

SECONDARY outcome

Timeframe: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

Outcome measures

Outcome measures
Measure	Patients With Prostate Cancer n=552 Participants Patients with prostate cancer who were receiving treatment with Lupron.
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Physician for Prostate Cancer Month 0	38 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Physician for Prostate Cancer Month 3	44 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Physician for Prostate Cancer Month 6	38 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Physician for Prostate Cancer Month 12	34 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Physician for Prostate Cancer Month 18	20 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Physician for Prostate Cancer Month 24	23 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Physician for Prostate Cancer Month 30	14 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Physician for Prostate Cancer Month 36	8 Participants

SECONDARY outcome

Timeframe: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

Population: All participants who had visited a physician and with available data at given time point.

Outcome measures

Outcome measures
Measure	Patients With Prostate Cancer n=552 Participants Patients with prostate cancer who were receiving treatment with Lupron.
Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Physician for Prostate Cancer Month 0	1.2 physician visits Standard Deviation 0.56
Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Physician for Prostate Cancer Month 3	1.5 physician visits Standard Deviation 0.84
Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Physician for Prostate Cancer Month 6	7.1 physician visits Standard Deviation 13.93
Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Physician for Prostate Cancer Month 12	1.6 physician visits Standard Deviation 1.17
Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Physician for Prostate Cancer Month 18	2.7 physician visits Standard Deviation 1.86
Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Physician for Prostate Cancer Month 24	2.4 physician visits Standard Deviation 1.14
Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Physician for Prostate Cancer Month 30	2.0 physician visits Standard Deviation 1.00
Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Physician for Prostate Cancer Month 36	2.0 physician visits Standard Deviation 0.00

SECONDARY outcome

Timeframe: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

Outcome measures

Outcome measures
Measure	Patients With Prostate Cancer n=552 Participants Patients with prostate cancer who were receiving treatment with Lupron.
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Healthcare Professional for Prostate Cancer Month 6	20 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Healthcare Professional for Prostate Cancer Month 18	8 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Healthcare Professional for Prostate Cancer Month 30	9 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Healthcare Professional for Prostate Cancer Month 36	3 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Healthcare Professional for Prostate Cancer Month 0	20 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Healthcare Professional for Prostate Cancer Month 3	23 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Healthcare Professional for Prostate Cancer Month 12	21 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Healthcare Professional for Prostate Cancer Month 24	11 Participants

SECONDARY outcome

Timeframe: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

Population: All participants who had visited a healthcare professional and with available data at given time point.

Outcome measures

Outcome measures
Measure	Patients With Prostate Cancer n=552 Participants Patients with prostate cancer who were receiving treatment with Lupron.
Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Healthcare Professional for Prostate Cancer Month 0	7.8 healthcare professional visits Standard Deviation 14.05
Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Healthcare Professional for Prostate Cancer Month 3	3.5 healthcare professional visits Standard Deviation 4.11
Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Healthcare Professional for Prostate Cancer Month 6	18.5 healthcare professional visits Standard Deviation 19.06
Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Healthcare Professional for Prostate Cancer Month 12	3.1 healthcare professional visits Standard Deviation 2.12
Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Healthcare Professional for Prostate Cancer Month 18	2.3 healthcare professional visits Standard Deviation 0.96
Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Healthcare Professional for Prostate Cancer Month 24	1.7 healthcare professional visits Standard Deviation 1.15
Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Healthcare Professional for Prostate Cancer Month 30	1.6 healthcare professional visits Standard Deviation 0.89

SECONDARY outcome

Timeframe: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

Outcome measures

Outcome measures
Measure	Patients With Prostate Cancer n=552 Participants Patients with prostate cancer who were receiving treatment with Lupron.
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Hospital Emergency Room for Prostate Cancer Month 0	9 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Hospital Emergency Room for Prostate Cancer Month 3	7 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Hospital Emergency Room for Prostate Cancer Month 6	3 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Hospital Emergency Room for Prostate Cancer Month 12	8 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Hospital Emergency Room for Prostate Cancer Month 18	5 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Hospital Emergency Room for Prostate Cancer Month 24	6 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Hospital Emergency Room for Prostate Cancer Month 30	4 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Hospital Emergency Room for Prostate Cancer Month 36	2 Participants

SECONDARY outcome

Timeframe: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

Population: All participants who had visited a hospital emergency room and with available data at given time point.

Outcome measures

Outcome measures
Measure	Patients With Prostate Cancer n=552 Participants Patients with prostate cancer who were receiving treatment with Lupron.
Health Care Utilization and Health Economics Questionnaire: Number of Visits to A Hospital Emergency Room for Prostate Cancer Month 0	1.2 hospital emergency room visits Standard Deviation 0.45
Health Care Utilization and Health Economics Questionnaire: Number of Visits to A Hospital Emergency Room for Prostate Cancer Month 3	1.0 hospital emergency room visits Standard Deviation NA The estimated standard deviation of one sample is undefined
Health Care Utilization and Health Economics Questionnaire: Number of Visits to A Hospital Emergency Room for Prostate Cancer Month 6	1.0 hospital emergency room visits Standard Deviation NA The estimated standard deviation of one sample is undefined
Health Care Utilization and Health Economics Questionnaire: Number of Visits to A Hospital Emergency Room for Prostate Cancer Month 12	1.4 hospital emergency room visits Standard Deviation 0.55
Health Care Utilization and Health Economics Questionnaire: Number of Visits to A Hospital Emergency Room for Prostate Cancer Month 18	1.0 hospital emergency room visits Standard Deviation NA The estimated standard deviation of one sample is undefined
Health Care Utilization and Health Economics Questionnaire: Number of Visits to A Hospital Emergency Room for Prostate Cancer Month 30	1.0 hospital emergency room visits Standard Deviation 0.00

SECONDARY outcome

Timeframe: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

Outcome measures

Outcome measures
Measure	Patients With Prostate Cancer n=552 Participants Patients with prostate cancer who were receiving treatment with Lupron.
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used an Ambulance Service for Prostate Cancer Month 6	4 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used an Ambulance Service for Prostate Cancer Month 0	4 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used an Ambulance Service for Prostate Cancer Month 3	2 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used an Ambulance Service for Prostate Cancer Month 12	2 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used an Ambulance Service for Prostate Cancer Month 18	2 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used an Ambulance Service for Prostate Cancer Month 24	3 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used an Ambulance Service for Prostate Cancer Month 30	2 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used an Ambulance Service for Prostate Cancer Month 36	1 Participants

SECONDARY outcome

Timeframe: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

Population: All participants who had used an ambulance service and with available data at given time point.

Outcome measures

Outcome measures
Measure	Patients With Prostate Cancer n=552 Participants Patients with prostate cancer who were receiving treatment with Lupron.
Health Care Utilization and Health Economics Questionnaire: Number of Times That an Ambulance Service Was Used for Prostate Cancer Month 0	1.0 ambulance service uses Standard Deviation NA The estimated standard deviation of one sample is undefined
Health Care Utilization and Health Economics Questionnaire: Number of Times That an Ambulance Service Was Used for Prostate Cancer Month 6	1.0 ambulance service uses Standard Deviation NA The estimated standard deviation of one sample is undefined
Health Care Utilization and Health Economics Questionnaire: Number of Times That an Ambulance Service Was Used for Prostate Cancer Month 18	1.0 ambulance service uses Standard Deviation NA The estimated standard deviation of one sample is undefined
Health Care Utilization and Health Economics Questionnaire: Number of Times That an Ambulance Service Was Used for Prostate Cancer Month 30	1.0 ambulance service uses Standard Deviation NA The estimated standard deviation of one sample is undefined

SECONDARY outcome

Timeframe: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

Outcome measures

Outcome measures
Measure	Patients With Prostate Cancer n=552 Participants Patients with prostate cancer who were receiving treatment with Lupron.
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited Complementary/Alternate Therapy for Prostate Cancer Month 36	1 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited Complementary/Alternate Therapy for Prostate Cancer Month 0	3 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited Complementary/Alternate Therapy for Prostate Cancer Month 3	2 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited Complementary/Alternate Therapy for Prostate Cancer Month 6	1 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited Complementary/Alternate Therapy for Prostate Cancer Month 12	4 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited Complementary/Alternate Therapy for Prostate Cancer Month 18	3 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited Complementary/Alternate Therapy for Prostate Cancer Month 24	0 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited Complementary/Alternate Therapy for Prostate Cancer Month 30	0 Participants

SECONDARY outcome

Timeframe: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

Population: All participants who had visited complementary/alternate therapy and with available data at given time point.

Outcome measures

Outcome measures
Measure	Patients With Prostate Cancer n=552 Participants Patients with prostate cancer who were receiving treatment with Lupron.
Health Care Utilization and Health Economics Questionnaire: Number of Visits For Complementary/Alternate Therapy for Prostate Cancer Month 12	3.5 complementary/alternate therapy visits Standard Deviation 2.12
Health Care Utilization and Health Economics Questionnaire: Number of Visits For Complementary/Alternate Therapy for Prostate Cancer Month 0	1.0 complementary/alternate therapy visits Standard Deviation NA The estimated standard deviation of one sample is undefined
Health Care Utilization and Health Economics Questionnaire: Number of Visits For Complementary/Alternate Therapy for Prostate Cancer Month 3	1.0 complementary/alternate therapy visits Standard Deviation NA The estimated standard deviation of one sample is undefined

SECONDARY outcome

Timeframe: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

Outcome measures

Outcome measures
Measure	Patients With Prostate Cancer n=552 Participants Patients with prostate cancer who were receiving treatment with Lupron.
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used Any Other Medical Service for Prostate Cancer Month 0	9 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used Any Other Medical Service for Prostate Cancer Month 3	8 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used Any Other Medical Service for Prostate Cancer Month 6	12 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used Any Other Medical Service for Prostate Cancer Month 12	9 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used Any Other Medical Service for Prostate Cancer Month 18	5 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used Any Other Medical Service for Prostate Cancer Month 24	6 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used Any Other Medical Service for Prostate Cancer Month 30	2 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used Any Other Medical Service for Prostate Cancer Month 36	2 Participants

SECONDARY outcome

Timeframe: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

Population: All participants who had visited for any other medical service and with available data at given time point.

Outcome measures

Outcome measures
Measure	Patients With Prostate Cancer n=552 Participants Patients with prostate cancer who were receiving treatment with Lupron.
Health Care Utilization and Health Economics Questionnaire: Number of Visits For Any Other Medical Service for Prostate Cancer Month 0	7.4 visits for any other medical service Standard Deviation 12.66
Health Care Utilization and Health Economics Questionnaire: Number of Visits For Any Other Medical Service for Prostate Cancer Month 3	2.0 visits for any other medical service Standard Deviation 2.00
Health Care Utilization and Health Economics Questionnaire: Number of Visits For Any Other Medical Service for Prostate Cancer Month 6	1.0 visits for any other medical service Standard Deviation NA The estimated standard deviation of one sample is undefined
Health Care Utilization and Health Economics Questionnaire: Number of Visits For Any Other Medical Service for Prostate Cancer Month 12	1.0 visits for any other medical service Standard Deviation 0.00
Health Care Utilization and Health Economics Questionnaire: Number of Visits For Any Other Medical Service for Prostate Cancer Month 36	1.0 visits for any other medical service Standard Deviation NA The estimated standard deviation of one sample is undefined

SECONDARY outcome

Timeframe: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

Outcome measures

Outcome measures
Measure	Patients With Prostate Cancer n=552 Participants Patients with prostate cancer who were receiving treatment with Lupron.
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Were Admitted to the Hospital for Prostate Cancer Month 0	29 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Were Admitted to the Hospital for Prostate Cancer Month 3	14 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Were Admitted to the Hospital for Prostate Cancer Month 6	9 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Were Admitted to the Hospital for Prostate Cancer Month 12	14 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Were Admitted to the Hospital for Prostate Cancer Month 18	9 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Were Admitted to the Hospital for Prostate Cancer Month 24	5 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Were Admitted to the Hospital for Prostate Cancer Month 30	4 Participants
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Were Admitted to the Hospital for Prostate Cancer Month 36	8 Participants

SECONDARY outcome

Timeframe: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

Population: All participants who were admitted to the hospital and with available data at given time point.

Outcome measures

Outcome measures
Measure	Patients With Prostate Cancer n=552 Participants Patients with prostate cancer who were receiving treatment with Lupron.
Health Care Utilization and Health Economics Questionnaire: Number of Admissions to the Hospital for Prostate Cancer Month 0	1.0 admissions to the hospital Standard Deviation 0.00
Health Care Utilization and Health Economics Questionnaire: Number of Admissions to the Hospital for Prostate Cancer Month 3	1.0 admissions to the hospital Standard Deviation 0.00
Health Care Utilization and Health Economics Questionnaire: Number of Admissions to the Hospital for Prostate Cancer Month 6	1.0 admissions to the hospital Standard Deviation 0.00
Health Care Utilization and Health Economics Questionnaire: Number of Admissions to the Hospital for Prostate Cancer Month 12	1.0 admissions to the hospital Standard Deviation 0.00
Health Care Utilization and Health Economics Questionnaire: Number of Admissions to the Hospital for Prostate Cancer Month 18	1.0 admissions to the hospital Standard Deviation 0.00
Health Care Utilization and Health Economics Questionnaire: Number of Admissions to the Hospital for Prostate Cancer Month 24	1.0 admissions to the hospital Standard Deviation 0.00
Health Care Utilization and Health Economics Questionnaire: Number of Admissions to the Hospital for Prostate Cancer Month 30	1.0 admissions to the hospital Standard Deviation 0.00
Health Care Utilization and Health Economics Questionnaire: Number of Admissions to the Hospital for Prostate Cancer Month 36	1.0 admissions to the hospital Standard Deviation 0.00

SECONDARY outcome

Timeframe: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

Population: All participants with out of pocket expenses for over-the-counter medications and with available data at given time point.

Outcome measures

Outcome measures
Measure	Patients With Prostate Cancer n=552 Participants Patients with prostate cancer who were receiving treatment with Lupron.
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Over-the-counter Medications for Prostate Cancer Month 0	21.5 dollars (CAD) Standard Deviation 73.50
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Over-the-counter Medications for Prostate Cancer Month 3	19.3 dollars (CAD) Standard Deviation 101.66
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Over-the-counter Medications for Prostate Cancer Month 6	25.5 dollars (CAD) Standard Deviation 130.41
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Over-the-counter Medications for Prostate Cancer Month 12	26.6 dollars (CAD) Standard Deviation 101.28
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Over-the-counter Medications for Prostate Cancer Month 18	20.9 dollars (CAD) Standard Deviation 80.53
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Over-the-counter Medications for Prostate Cancer Month 24	13.9 dollars (CAD) Standard Deviation 60.01
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Over-the-counter Medications for Prostate Cancer Month 30	13.4 dollars (CAD) Standard Deviation 54.69
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Over-the-counter Medications for Prostate Cancer Month 36	13.1 dollars (CAD) Standard Deviation 55.12

SECONDARY outcome

Timeframe: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

Population: All participants with out of pocket expenses for payments to health care professionals and with available data at given time point.

Outcome measures

Outcome measures
Measure	Patients With Prostate Cancer n=552 Participants Patients with prostate cancer who were receiving treatment with Lupron.
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments to Health Care Professionals for Prostate Cancer Month 0	0.9 dollars (CAD) Standard Deviation 11.66
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments to Health Care Professionals for Prostate Cancer Month 3	2.5 dollars (CAD) Standard Deviation 30.24
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments to Health Care Professionals for Prostate Cancer Month 6	2.5 dollars (CAD) Standard Deviation 31.18
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments to Health Care Professionals for Prostate Cancer Month 12	0.8 dollars (CAD) Standard Deviation 12.80
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments to Health Care Professionals for Prostate Cancer Month 18	2.4 dollars (CAD) Standard Deviation 34.67
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments to Health Care Professionals for Prostate Cancer Month 24	2.6 dollars (CAD) Standard Deviation 36.27
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments to Health Care Professionals for Prostate Cancer Month 30	1.6 dollars (CAD) Standard Deviation 19.95
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments to Health Care Professionals for Prostate Cancer Month 36	7.9 dollars (CAD) Standard Deviation 62.50

SECONDARY outcome

Timeframe: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

Population: All participants with out of pocket expenses for medical procedures and with available data at given time point.

Outcome measures

Outcome measures
Measure	Patients With Prostate Cancer n=552 Participants Patients with prostate cancer who were receiving treatment with Lupron.
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Procedures for Prostate Cancer Month 0	14.0 dollars (CAD) Standard Deviation 91.76
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Procedures for Prostate Cancer Month 3	2.6 dollars (CAD) Standard Deviation 22.01
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Procedures for Prostate Cancer Month 6	4.1 dollars (CAD) Standard Deviation 33.59
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Procedures for Prostate Cancer Month 12	3.0 dollars (CAD) Standard Deviation 20.96
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Procedures for Prostate Cancer Month 18	2.7 dollars (CAD) Standard Deviation 18.39
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Procedures for Prostate Cancer Month 24	6.8 dollars (CAD) Standard Deviation 54.35
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Procedures for Prostate Cancer Month 30	5.2 dollars (CAD) Standard Deviation 35.89
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Procedures for Prostate Cancer Month 36	2.9 dollars (CAD) Standard Deviation 20.11

SECONDARY outcome

Timeframe: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

Population: All participants with out of pocket expenses for payments for medical procedures or laboratory tests and with available data at given time point.

Outcome measures

Outcome measures
Measure	Patients With Prostate Cancer n=552 Participants Patients with prostate cancer who were receiving treatment with Lupron.
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments for Medical Procedures or Laboratory Tests for Prostate Cancer Month 3	2.6 dollars (CAD) Standard Deviation 22.01
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments for Medical Procedures or Laboratory Tests for Prostate Cancer Month 0	14.0 dollars (CAD) Standard Deviation 91.76
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments for Medical Procedures or Laboratory Tests for Prostate Cancer Month 6	4.1 dollars (CAD) Standard Deviation 33.59
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments for Medical Procedures or Laboratory Tests for Prostate Cancer Month 12	3.0 dollars (CAD) Standard Deviation 20.96
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments for Medical Procedures or Laboratory Tests for Prostate Cancer Month 18	2.7 dollars (CAD) Standard Deviation 18.39
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments for Medical Procedures or Laboratory Tests for Prostate Cancer Month 24	6.8 dollars (CAD) Standard Deviation 54.35
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments for Medical Procedures or Laboratory Tests for Prostate Cancer Month 30	5.2 dollars (CAD) Standard Deviation 35.89
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments for Medical Procedures or Laboratory Tests for Prostate Cancer Month 36	2.9 dollars (CAD) Standard Deviation 20.11

SECONDARY outcome

Timeframe: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

Population: All participants with out of pocket expenses for medical devices and with available data at given time point.

Outcome measures

Outcome measures
Measure	Patients With Prostate Cancer n=552 Participants Patients with prostate cancer who were receiving treatment with Lupron.
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Devices for Prostate Cancer Month 0	4.0 dollars (CAD) Standard Deviation 40.46
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Devices for Prostate Cancer Month 3	7.5 dollars (CAD) Standard Deviation 58.00
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Devices for Prostate Cancer Month 6	21.0 dollars (CAD) Standard Deviation 292.53
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Devices for Prostate Cancer Month 12	7.3 dollars (CAD) Standard Deviation 96.50
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Devices for Prostate Cancer Month 18	2.1 dollars (CAD) Standard Deviation 16.79
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Devices for Prostate Cancer Month 24	2.4 dollars (CAD) Standard Deviation 22.88
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Devices for Prostate Cancer Month 30	1.5 dollars (CAD) Standard Deviation 12.96
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Devices for Prostate Cancer Month 36	2.0 dollars (CAD) Standard Deviation 24.66

SECONDARY outcome

Timeframe: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

Population: All participants with out of pocket expenses for health care or extra help at home and with available data at given time point.

Outcome measures

Outcome measures
Measure	Patients With Prostate Cancer n=552 Participants Patients with prostate cancer who were receiving treatment with Lupron.
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Health Care or Extra Help At Home for Prostate Cancer Month 0	4.9 dollars (CAD) Standard Deviation 58.06
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Health Care or Extra Help At Home for Prostate Cancer Month 3	4.9 dollars (CAD) Standard Deviation 60.31
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Health Care or Extra Help At Home for Prostate Cancer Month 6	14.7 dollars (CAD) Standard Deviation 189.44
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Health Care or Extra Help At Home for Prostate Cancer Month 12	28.9 dollars (CAD) Standard Deviation 390.75
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Health Care or Extra Help At Home for Prostate Cancer Month 18	0.4 dollars (CAD) Standard Deviation 6.21
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Health Care or Extra Help At Home for Prostate Cancer Month 24	1.4 dollars (CAD) Standard Deviation 14.26
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Health Care or Extra Help At Home for Prostate Cancer Month 30	3.0 dollars (CAD) Standard Deviation 24.16
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Health Care or Extra Help At Home for Prostate Cancer Month 36	11.8 dollars (CAD) Standard Deviation 92.40

SECONDARY outcome

Timeframe: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

Population: All participants with out of pocket expenses for transportation costs and with available data at given time point.

Outcome measures

Outcome measures
Measure	Patients With Prostate Cancer n=552 Participants Patients with prostate cancer who were receiving treatment with Lupron.
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Transportation Costs for Prostate Cancer Month 0	20.0 dollars (CAD) Standard Deviation 124.86
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Transportation Costs for Prostate Cancer Month 3	19.5 dollars (CAD) Standard Deviation 77.92
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Transportation Costs for Prostate Cancer Month 6	23.0 dollars (CAD) Standard Deviation 96.03
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Transportation Costs for Prostate Cancer Month 12	9.2 dollars (CAD) Standard Deviation 27.87
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Transportation Costs for Prostate Cancer Month 18	6.3 dollars (CAD) Standard Deviation 19.88
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Transportation Costs for Prostate Cancer Month 24	10.6 dollars (CAD) Standard Deviation 87.22
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Transportation Costs for Prostate Cancer Month 30	8.2 dollars (CAD) Standard Deviation 26.54
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Transportation Costs for Prostate Cancer Month 36	2.7 dollars (CAD) Standard Deviation 9.30

SECONDARY outcome

Timeframe: Months 3, 6, 12, 18, 24, 30, and 36

Population: All participants with available data at given time point.

Treatment compliance by participants was assessed as the number of missed injections since the last visit.

Outcome measures

Outcome measures
Measure	Patients With Prostate Cancer n=552 Participants Patients with prostate cancer who were receiving treatment with Lupron.
Treatment Compliance Month 3	0.0 missed injections Standard Deviation 0.12
Treatment Compliance Month 6	0.0 missed injections Standard Deviation 0.17
Treatment Compliance Month 12	0.1 missed injections Standard Deviation 0.35
Treatment Compliance Month 18	0.2 missed injections Standard Deviation 0.53
Treatment Compliance Month 24	0.2 missed injections Standard Deviation 0.66
Treatment Compliance Month 30	0.2 missed injections Standard Deviation 0.57
Treatment Compliance Month 36	0.2 missed injections Standard Deviation 0.83

SECONDARY outcome

Timeframe: Months 3, 6, 12, 18, 24, 30, and 36

Population: The number of participants with changes in current prostate cancer treatment since the last visit at given time point.

Participants were asked "Have there been any changes in the current prostate cancer treatment (not including Lupron) since last visit?"; if Yes, was the change "Initiation of new mediation/Change in Dose/Frequency" or "Discontinuation of medication". The percentage of subjects at each visit with a change in current prostate cancer treatment (Initiation or Change in Dose/Frequency or Discontinuation of Medication) is presented.

Outcome measures

Outcome measures
Measure	Patients With Prostate Cancer n=522 Participants Patients with prostate cancer who were receiving treatment with Lupron.
Percentage of Participants With Changes in Current Prostate Cancer Treatment Since Last Visit. Month 3 Initiation or Change in Dose/Frequency	9.4 percentage of participants
Percentage of Participants With Changes in Current Prostate Cancer Treatment Since Last Visit. Month 3 Discontinuation of Medication	90.6 percentage of participants
Percentage of Participants With Changes in Current Prostate Cancer Treatment Since Last Visit. Month 6 Initiation or Change in Dose/Frequency	42.6 percentage of participants
Percentage of Participants With Changes in Current Prostate Cancer Treatment Since Last Visit. Month 6 Discontinuation of Medication	57.4 percentage of participants
Percentage of Participants With Changes in Current Prostate Cancer Treatment Since Last Visit. Month 12 Initiation or Change in Dose/Frequency	54.1 percentage of participants
Percentage of Participants With Changes in Current Prostate Cancer Treatment Since Last Visit. Month 12 Discontinuation of Medication	45.9 percentage of participants
Percentage of Participants With Changes in Current Prostate Cancer Treatment Since Last Visit. Month 18 Initiation or Change in Dose/Frequency	45.0 percentage of participants
Percentage of Participants With Changes in Current Prostate Cancer Treatment Since Last Visit. Month 18 Discontinuation of Medication	45.0 percentage of participants
Percentage of Participants With Changes in Current Prostate Cancer Treatment Since Last Visit. Month 24 Initiation or Change in Dose/Frequency	60.0 percentage of participants
Percentage of Participants With Changes in Current Prostate Cancer Treatment Since Last Visit. Month 24 Discontinuation of Medication	40.0 percentage of participants
Percentage of Participants With Changes in Current Prostate Cancer Treatment Since Last Visit. Month 30 Initiation or Change in Dose/Frequency	71.4 percentage of participants
Percentage of Participants With Changes in Current Prostate Cancer Treatment Since Last Visit. Month 30 Discontinuation of Medication	28.6 percentage of participants
Percentage of Participants With Changes in Current Prostate Cancer Treatment Since Last Visit. Month 36 Initiation or Change in Dose/Frequency	57.1 percentage of participants
Percentage of Participants With Changes in Current Prostate Cancer Treatment Since Last Visit. Month 36 Discontinuation of Medication	42.9 percentage of participants

Adverse Events

Patients With Prostate Cancer

Serious events: 132 serious events

Other events: 77 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Patients With Prostate Cancer n=552 participants at risk Patients with prostate cancer who were receiving treatment with Lupron.
Blood and lymphatic system disorders ANAEMIA	0.91% 5/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Blood and lymphatic system disorders BANDAEMIA	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Blood and lymphatic system disorders LYMPHADENOPATHY	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Blood and lymphatic system disorders NEUTROPENIA	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Blood and lymphatic system disorders THROMBOCYTOPENIA	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Cardiac disorders ACUTE CORONARY SYNDROME	0.72% 4/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Cardiac disorders ANGINA PECTORIS	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Cardiac disorders ANGINA UNSTABLE	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Cardiac disorders AORTIC VALVE STENOSIS	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Cardiac disorders ARRHYTHMIA	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Cardiac disorders ATRIAL FIBRILLATION	1.4% 8/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Cardiac disorders BUNDLE BRANCH BLOCK RIGHT	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Cardiac disorders CARDIAC ARREST	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Cardiac disorders CARDIAC DISORDER	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Cardiac disorders CARDIAC FAILURE	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Cardiac disorders CARDIAC FAILURE CONGESTIVE	1.6% 9/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Cardiac disorders CARDIOMEGALY	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Cardiac disorders CORONARY ARTERY DISEASE	0.54% 3/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Cardiac disorders ISCHAEMIC CARDIOMYOPATHY	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Cardiac disorders LEFT VENTRICULAR HYPERTROPHY	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Cardiac disorders MITRAL VALVE INCOMPETENCE	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Cardiac disorders MYOCARDIAL INFARCTION	1.4% 8/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Cardiac disorders MYOCARDIAL ISCHAEMIA	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Cardiac disorders PALPITATIONS	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Cardiac disorders SINUS BRADYCARDIA	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Cardiac disorders TACHYCARDIA	0.54% 3/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Ear and labyrinth disorders DEAFNESS	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Ear and labyrinth disorders VERTIGO	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Eye disorders DIPLOPIA	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Eye disorders OCULAR MYASTHENIA	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Gastrointestinal disorders ABDOMINAL MASS	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Gastrointestinal disorders ABDOMINAL PAIN	1.1% 6/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Gastrointestinal disorders COELIAC DISEASE	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Gastrointestinal disorders COLITIS ISCHAEMIC	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Gastrointestinal disorders CONSTIPATION	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Gastrointestinal disorders DIARRHOEA HAEMORRHAGIC	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Gastrointestinal disorders DIVERTICULUM	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Gastrointestinal disorders EPIGASTRIC DISCOMFORT	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Gastrointestinal disorders GASTRIC ULCER	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Gastrointestinal disorders GASTROINTESTINAL HAEMORRHAGE	0.54% 3/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Gastrointestinal disorders HAEMATEMESIS	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Gastrointestinal disorders HIATUS HERNIA	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Gastrointestinal disorders INTESTINAL MASS	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Gastrointestinal disorders INTESTINAL OBSTRUCTION	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Gastrointestinal disorders IRRITABLE BOWEL SYNDROME	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Gastrointestinal disorders LARGE INTESTINAL OBSTRUCTION	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Gastrointestinal disorders NAUSEA	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Gastrointestinal disorders NEUTROPENIC COLITIS	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Gastrointestinal disorders RECTAL HAEMORRHAGE	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Gastrointestinal disorders VOMITING	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
General disorders ASTHENIA	1.3% 7/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
General disorders CHEST PAIN	0.54% 3/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
General disorders CHILLS	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
General disorders CONDITION AGGRAVATED	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
General disorders DEATH	1.3% 7/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
General disorders DISEASE PROGRESSION	1.3% 7/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
General disorders DRUG INEFFECTIVE	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
General disorders FATIGUE	0.72% 4/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
General disorders GAIT DISTURBANCE	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
General disorders GENERAL PHYSICAL HEALTH DETERIORATION	0.72% 4/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
General disorders IMPAIRED SELF-CARE	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
General disorders INFLAMMATION	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
General disorders LOCAL SWELLING	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
General disorders MALAISE	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
General disorders NO THERAPEUTIC RESPONSE	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
General disorders OBSTRUCTION	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
General disorders OEDEMA PERIPHERAL	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
General disorders PAIN	0.72% 4/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
General disorders PELVIC MASS	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
General disorders PYREXIA	0.91% 5/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
General disorders UNEVALUABLE EVENT	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Hepatobiliary disorders HEPATIC LESION	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Immune system disorders IMMUNOSUPPRESSION	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Infections and infestations DEVICE RELATED INFECTION	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Infections and infestations ENDOCARDITIS BACTERIAL	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Infections and infestations ESCHERICHIA INFECTION	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Infections and infestations GASTROENTERITIS	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Infections and infestations GASTROENTERITIS ESCHERICHIA COLI	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Infections and infestations INFECTION	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Infections and infestations INFLUENZA	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Infections and infestations PNEUMONIA	0.91% 5/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Infections and infestations PYELONEPHRITIS ACUTE	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Infections and infestations SEPSIS	0.54% 3/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Infections and infestations SEPTIC SHOCK	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Infections and infestations STAPHYLOCOCCAL BACTERAEMIA	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Infections and infestations STAPHYLOCOCCAL INFECTION	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Infections and infestations STAPHYLOCOCCAL SEPSIS	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Infections and infestations URINARY TRACT INFECTION	0.54% 3/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Infections and infestations UROSEPSIS	0.54% 3/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Injury, poisoning and procedural complications ANAESTHETIC COMPLICATION	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Injury, poisoning and procedural complications CERVICAL VERTEBRAL FRACTURE	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Injury, poisoning and procedural complications FALL	2.0% 11/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Injury, poisoning and procedural complications FEMORAL NECK FRACTURE	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Injury, poisoning and procedural complications FIBULA FRACTURE	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Injury, poisoning and procedural complications HEAD INJURY	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Injury, poisoning and procedural complications HIP FRACTURE	0.72% 4/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Injury, poisoning and procedural complications JOINT DISLOCATION	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Injury, poisoning and procedural complications OVERDOSE	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Injury, poisoning and procedural complications PELVIC FRACTURE	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Injury, poisoning and procedural complications POST PROCEDURAL HAEMORRHAGE	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Injury, poisoning and procedural complications RIB FRACTURE	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Injury, poisoning and procedural complications SPINAL COMPRESSION FRACTURE	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Injury, poisoning and procedural complications SPINAL FRACTURE	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Injury, poisoning and procedural complications TIBIA FRACTURE	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Injury, poisoning and procedural complications TRACHEOSTOMY MALFUNCTION	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Injury, poisoning and procedural complications TRAUMATIC LUNG INJURY	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Injury, poisoning and procedural complications UPPER LIMB FRACTURE	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Injury, poisoning and procedural complications URINARY RETENTION POSTOPERATIVE	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Injury, poisoning and procedural complications WRIST FRACTURE	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Investigations BLOOD ALBUMIN DECREASED	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Investigations BLOOD CREATININE INCREASED	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Investigations BLOOD URINE PRESENT	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Investigations BRAIN NATRIURETIC PEPTIDE INCREASED	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Investigations EJECTION FRACTION ABNORMAL	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Investigations ELECTROCARDIOGRAM ST SEGMENT DEPRESSION	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Investigations EXERCISE ELECTROCARDIOGRAM ABNORMAL	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Investigations HAEMOGLOBIN DECREASED	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Investigations OXYGEN SATURATION DECREASED	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Investigations PROSTATIC SPECIFIC ANTIGEN INCREASED	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Investigations SCAN MYOCARDIAL PERFUSION ABNORMAL	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Investigations STAPHYLOCOCCUS TEST POSITIVE	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Investigations TROPONIN INCREASED	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Investigations VENOUS PRESSURE JUGULAR INCREASED	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Investigations WEIGHT DECREASED	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Investigations WHITE BLOOD CELL COUNT DECREASED	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Investigations WHITE BLOOD CELL COUNT INCREASED	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Metabolism and nutrition disorders ACIDOSIS	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Metabolism and nutrition disorders DECREASED APPETITE	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Metabolism and nutrition disorders DEHYDRATION	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Metabolism and nutrition disorders DIABETES MELLITUS	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Metabolism and nutrition disorders FAILURE TO THRIVE	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Metabolism and nutrition disorders HYPERCALCAEMIA	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Metabolism and nutrition disorders HYPERGLYCAEMIA	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Metabolism and nutrition disorders HYPERKALAEMIA	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Metabolism and nutrition disorders HYPOCALCAEMIA	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Metabolism and nutrition disorders HYPOGLYCAEMIA	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Metabolism and nutrition disorders HYPOKALAEMIA	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Metabolism and nutrition disorders HYPONATRAEMIA	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Metabolism and nutrition disorders HYPOPHOSPHATAEMIA	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Metabolism and nutrition disorders HYPOVOLAEMIA	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Metabolism and nutrition disorders MALNUTRITION	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Musculoskeletal and connective tissue disorders BACK PAIN	0.54% 3/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Musculoskeletal and connective tissue disorders BONE PAIN	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Musculoskeletal and connective tissue disorders JOINT SWELLING	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Musculoskeletal and connective tissue disorders MOBILITY DECREASED	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Musculoskeletal and connective tissue disorders OSTEOARTHRITIS	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BILIARY NEOPLASM	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BLADDER CANCER	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BLADDER TRANSITIONAL CELL CARCINOMA	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CANCER PAIN	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CHOLESTEATOMA	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CHRONIC LYMPHOCYTIC LEUKAEMIA	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) COLON CANCER	0.72% 4/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) COLON CANCER METASTATIC	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) COLON NEOPLASM	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) GASTROINTESTINAL STROMAL TUMOUR	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) HIGH GRADE B-CELL LYMPHOMA BURKITT-LIKE LYMPHOMA	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) HORMONE-REFRACTORY PROSTATE CANCER	0.54% 3/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG ADENOCARCINOMA STAGE I	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG NEOPLASM MALIGNANT	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MESOTHELIOMA	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTASES TO BONE	1.8% 10/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTASES TO LIVER	0.54% 3/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTASES TO LUNG	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTASES TO RECTUM	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTASIS	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTATIC NEOPLASM	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEOPLASM PROGRESSION	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PLASMA CELL MYELOMA	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PROSTATE CANCER	1.8% 10/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PROSTATE CANCER METASTATIC	2.5% 14/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PROSTATE CANCER STAGE IV	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SQUAMOUS CELL CARCINOMA OF PHARYNX	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Nervous system disorders BALANCE DISORDER	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Nervous system disorders CAUDA EQUINA SYNDROME	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Nervous system disorders CEREBROVASCULAR ACCIDENT	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Nervous system disorders COMA	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Nervous system disorders DEMENTIA	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Nervous system disorders DIZZINESS	0.54% 3/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Nervous system disorders HEADACHE	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Nervous system disorders LOSS OF CONSCIOUSNESS	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Nervous system disorders SEIZURE	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Nervous system disorders SYNCOPE	0.72% 4/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Nervous system disorders UNRESPONSIVE TO STIMULI	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Product Issues DEVICE OCCLUSION	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Psychiatric disorders ANXIETY	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Psychiatric disorders CONFUSIONAL STATE	0.54% 3/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Psychiatric disorders DELIRIUM	0.54% 3/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Psychiatric disorders DELUSION	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Psychiatric disorders DISORIENTATION	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Psychiatric disorders PARANOIA	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Renal and urinary disorders ACUTE KIDNEY INJURY	1.1% 6/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Renal and urinary disorders CALCULUS BLADDER	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Renal and urinary disorders DYSURIA	0.72% 4/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Renal and urinary disorders HAEMATURIA	0.72% 4/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Renal and urinary disorders INCONTINENCE	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Renal and urinary disorders INTERCAPILLARY GLOMERULOSCLEROSIS	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Renal and urinary disorders NEPHROLITHIASIS	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Renal and urinary disorders OBSTRUCTIVE UROPATHY	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Renal and urinary disorders POLLAKIURIA	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Renal and urinary disorders RENAL CYST	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Renal and urinary disorders RENAL FAILURE	0.72% 4/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Renal and urinary disorders URETERIC OBSTRUCTION	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Renal and urinary disorders URINARY BLADDER HAEMORRHAGE	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Renal and urinary disorders URINARY RETENTION	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Reproductive system and breast disorders BENIGN PROSTATIC HYPERPLASIA	0.54% 3/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Reproductive system and breast disorders PROSTATIC OBSTRUCTION	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Reproductive system and breast disorders PROSTATOMEGALY	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Respiratory, thoracic and mediastinal disorders ALVEOLITIS	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Respiratory, thoracic and mediastinal disorders ASTHMA	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Respiratory, thoracic and mediastinal disorders ATELECTASIS	0.54% 3/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Respiratory, thoracic and mediastinal disorders BRONCHIAL HYPERREACTIVITY	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Respiratory, thoracic and mediastinal disorders BRONCHIECTASIS	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Respiratory, thoracic and mediastinal disorders CHRONIC OBSTRUCTIVE PULMONARY DISEASE	0.91% 5/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Respiratory, thoracic and mediastinal disorders DYSPNOEA	2.0% 11/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Respiratory, thoracic and mediastinal disorders DYSPNOEA EXERTIONAL	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Respiratory, thoracic and mediastinal disorders HAEMOTHORAX	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Respiratory, thoracic and mediastinal disorders HYPOXIA	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Respiratory, thoracic and mediastinal disorders LUNG CONSOLIDATION	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Respiratory, thoracic and mediastinal disorders LUNG DISORDER	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	0.72% 4/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Respiratory, thoracic and mediastinal disorders PNEUMOTHORAX	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	0.54% 3/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Respiratory, thoracic and mediastinal disorders PULMONARY FIBROSIS	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Respiratory, thoracic and mediastinal disorders PULMONARY OEDEMA	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Respiratory, thoracic and mediastinal disorders RESPIRATORY ARREST	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Respiratory, thoracic and mediastinal disorders RESPIRATORY DISTRESS	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Respiratory, thoracic and mediastinal disorders RESPIRATORY FAILURE	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Respiratory, thoracic and mediastinal disorders SLEEP APNOEA SYNDROME	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Skin and subcutaneous tissue disorders COLD SWEAT	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Skin and subcutaneous tissue disorders ERYTHEMA	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Skin and subcutaneous tissue disorders RASH ERYTHEMATOUS	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Skin and subcutaneous tissue disorders RASH MACULO-PAPULAR	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Skin and subcutaneous tissue disorders RASH PRURITIC	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Social circumstances ACTIVITIES OF DAILY LIVING IMPAIRED	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Surgical and medical procedures BLADDER CALCULUS REMOVAL	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Surgical and medical procedures HIP ARTHROPLASTY	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Surgical and medical procedures HYDROCELE OPERATION	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Surgical and medical procedures STERNOTOMY	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Surgical and medical procedures TRANSURETHRAL PROSTATECTOMY	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Surgical and medical procedures URINARY CYSTECTOMY	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Vascular disorders ANGIOPATHY	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Vascular disorders AORTIC STENOSIS	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Vascular disorders BLEEDING VARICOSE VEIN	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Vascular disorders DEEP VEIN THROMBOSIS	0.72% 4/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Vascular disorders HYPERTENSION	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Vascular disorders HYPOTENSION	0.54% 3/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).

Other adverse events

Other adverse events
Measure	Patients With Prostate Cancer n=552 participants at risk Patients with prostate cancer who were receiving treatment with Lupron.
Blood and lymphatic system disorders LEUKOCYTE VACUOLISATION	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Blood and lymphatic system disorders LYMPHADENOPATHY	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Cardiac disorders ATRIAL FIBRILLATION	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Cardiac disorders CORONARY ARTERY DISEASE	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Ear and labyrinth disorders EAR PAIN	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Eye disorders OCULAR MYASTHENIA	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Gastrointestinal disorders CONSTIPATION	0.54% 3/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Gastrointestinal disorders DIARRHOEA	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Gastrointestinal disorders DYSPHAGIA	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Gastrointestinal disorders HAEMORRHOIDS	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Gastrointestinal disorders NAUSEA	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
General disorders ASTHENIA	0.54% 3/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
General disorders CHEST DISCOMFORT	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
General disorders CHEST PAIN	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
General disorders CHILLS	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
General disorders DISEASE PROGRESSION	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
General disorders DRUG INEFFECTIVE	1.1% 6/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
General disorders FATIGUE	1.6% 9/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
General disorders GAIT DISTURBANCE	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
General disorders GENERAL PHYSICAL HEALTH DETERIORATION	0.54% 3/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
General disorders INJECTION SITE ERYTHEMA	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
General disorders INJECTION SITE PAIN	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
General disorders INJECTION SITE REACTION	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
General disorders INJECTION SITE SWELLING	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
General disorders INJECTION SITE ULCER	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
General disorders MALAISE	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
General disorders NODULE	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
General disorders OEDEMA PERIPHERAL	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
General disorders PAIN	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Hepatobiliary disorders HEPATIC LESION	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Immune system disorders DRUG HYPERSENSITIVITY	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Infections and infestations DYSENTERY	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Infections and infestations INFECTION	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Infections and infestations PNEUMONIA	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Infections and infestations URINARY TRACT INFECTION	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Infections and infestations URINARY TRACT INFECTION ENTEROCOCCAL	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Injury, poisoning and procedural complications FALL	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Injury, poisoning and procedural complications RADIATION ASSOCIATED PAIN	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Injury, poisoning and procedural complications SPINAL FRACTURE	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Investigations BLOOD CREATININE ABNORMAL	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Investigations BLOOD CREATININE INCREASED	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Investigations BLOOD TESTOSTERONE	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Investigations BLOOD TESTOSTERONE INCREASED	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Investigations GLYCOSYLATED HAEMOGLOBIN INCREASED	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Investigations HAEMOGLOBIN ABNORMAL	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Investigations LIVER FUNCTION TEST ABNORMAL	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Investigations NEUTROPHIL COUNT INCREASED	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Investigations NEUTROPHIL TOXIC GRANULATION PRESENT	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Investigations OXYGEN SATURATION DECREASED	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Investigations PROSTATIC SPECIFIC ANTIGEN INCREASED	0.72% 4/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Investigations WEIGHT DECREASED	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Investigations WEIGHT INCREASED	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Investigations WHITE BLOOD CELL COUNT ABNORMAL	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Investigations WHITE BLOOD CELL COUNT INCREASED	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Metabolism and nutrition disorders CACHEXIA	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Metabolism and nutrition disorders DECREASED APPETITE	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Metabolism and nutrition disorders DIABETES MELLITUS	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Metabolism and nutrition disorders DIABETES MELLITUS INADEQUATE CONTROL	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Metabolism and nutrition disorders FLUID INTAKE REDUCED	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Metabolism and nutrition disorders HYPERCHOLESTEROLAEMIA	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Metabolism and nutrition disorders HYPERLIPIDAEMIA	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Metabolism and nutrition disorders HYPOGLYCAEMIA	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Metabolism and nutrition disorders HYPOKALAEMIA	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Metabolism and nutrition disorders HYPONATRAEMIA	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Metabolism and nutrition disorders HYPOPHAGIA	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.54% 3/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Musculoskeletal and connective tissue disorders BACK PAIN	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Musculoskeletal and connective tissue disorders BONE LESION	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Musculoskeletal and connective tissue disorders BONE PAIN	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Musculoskeletal and connective tissue disorders GROIN PAIN	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Musculoskeletal and connective tissue disorders JOINT DESTRUCTION	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Musculoskeletal and connective tissue disorders JOINT SWELLING	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Musculoskeletal and connective tissue disorders MOBILITY DECREASED	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Musculoskeletal and connective tissue disorders MUSCULAR WEAKNESS	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL STIFFNESS	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Musculoskeletal and connective tissue disorders MYALGIA	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Musculoskeletal and connective tissue disorders OSTEONECROSIS	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Musculoskeletal and connective tissue disorders SPINAL OSTEOARTHRITIS	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Musculoskeletal and connective tissue disorders WEIGHT BEARING DIFFICULTY	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LARYNGEAL CANCER	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG NEOPLASM	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTASES TO BONE	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTATIC NEOPLASM	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEOPLASM MALIGNANT	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PROSTATE CANCER METASTATIC	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RECTAL CANCER	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Nervous system disorders DEMENTIA	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Nervous system disorders DIZZINESS	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Nervous system disorders DYSGEUSIA	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Nervous system disorders HEADACHE	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Nervous system disorders HYPOAESTHESIA	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Nervous system disorders LETHARGY	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Nervous system disorders MEMORY IMPAIRMENT	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Nervous system disorders NEURALGIA	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Nervous system disorders SYNCOPE	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Nervous system disorders TREMOR	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Psychiatric disorders CONFUSIONAL STATE	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Psychiatric disorders DEPRESSION	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Psychiatric disorders EMOTIONAL DISORDER	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Psychiatric disorders EUPHORIC MOOD	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Psychiatric disorders LISTLESS	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Psychiatric disorders PSYCHIATRIC DECOMPENSATION	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Renal and urinary disorders HAEMATURIA	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Renal and urinary disorders NEPHROLITHIASIS	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Renal and urinary disorders NOCTURIA	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Renal and urinary disorders RENAL FAILURE	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Renal and urinary disorders URINARY RETENTION	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Reproductive system and breast disorders PELVIC PAIN	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Reproductive system and breast disorders PROSTATIC OBSTRUCTION	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Respiratory, thoracic and mediastinal disorders COUGH	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Respiratory, thoracic and mediastinal disorders DYSPHONIA	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Respiratory, thoracic and mediastinal disorders DYSPNOEA	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Respiratory, thoracic and mediastinal disorders EPISTAXIS	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Respiratory, thoracic and mediastinal disorders LUNG CONSOLIDATION	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Respiratory, thoracic and mediastinal disorders RALES	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Respiratory, thoracic and mediastinal disorders RHINORRHOEA	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Respiratory, thoracic and mediastinal disorders SNEEZING	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Respiratory, thoracic and mediastinal disorders THROAT IRRITATION	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Skin and subcutaneous tissue disorders ALOPECIA	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Skin and subcutaneous tissue disorders HYPERHIDROSIS	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Skin and subcutaneous tissue disorders NIGHT SWEATS	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Skin and subcutaneous tissue disorders RASH GENERALISED	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Social circumstances ACTIVITIES OF DAILY LIVING IMPAIRED	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Surgical and medical procedures RADIOTHERAPY TO PROSTATE	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Vascular disorders DEEP VEIN THROMBOSIS	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Vascular disorders HAEMODYNAMIC INSTABILITY	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Vascular disorders HOT FLUSH	2.7% 15/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Vascular disorders HYPOTENSION	0.36% 2/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Vascular disorders PALLOR	0.18% 1/552 • Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).

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