Trial Outcomes & Findings for Study to Document Treatment Patterns and to Evaluate Leuprolide and Alternative Therapeutic Approaches to the Treatments of Advanced Prostate Cancer (NCT NCT01081873)
NCT ID: NCT01081873
Last Updated: 2012-10-31
Results Overview
The number of participants with metastases that are absent, local tumor, single metastases, multiple metastases in 1 organ, and multiple metastases in multiple organs at each visit is summarized.
Recruitment status
COMPLETED
Target enrollment
2717 participants
Primary outcome timeframe
time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first
Results posted on
2012-10-31
Participant Flow
Participant milestones
| Measure |
Advanced Prostate Cancer Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
|
|---|---|
|
Overall Study
STARTED
|
2714
|
|
Overall Study
COMPLETED
|
2416
|
|
Overall Study
NOT COMPLETED
|
298
|
Reasons for withdrawal
| Measure |
Advanced Prostate Cancer Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
|
|---|---|
|
Overall Study
Death
|
86
|
|
Overall Study
Withdrawal by Subject
|
10
|
|
Overall Study
Lost to Follow-up
|
142
|
|
Overall Study
Progression of prostate cancer
|
13
|
|
Overall Study
Other
|
47
|
Baseline Characteristics
Study to Document Treatment Patterns and to Evaluate Leuprolide and Alternative Therapeutic Approaches to the Treatments of Advanced Prostate Cancer
Baseline characteristics by cohort
| Measure |
Advanced Prostate Cancer Participants
n=2714 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses. Age was available for 2,691 patients only; age was missing for 23 patients who were thus not included in the age results.
|
|---|---|
|
Age Continuous
|
75.39 years
STANDARD_DEVIATION 7.92 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2714 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came firstPopulation: Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data at each visit.
The number of participants with metastases that are absent, local tumor, single metastases, multiple metastases in 1 organ, and multiple metastases in multiple organs at each visit is summarized.
Outcome measures
| Measure |
Advanced Prostate Cancer Participants at Baseline
n=1262 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at baseline.
|
Advanced Prostate Cancer Participants at Month 3
n=119 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 3.
|
Advanced Prostate Cancer Participants at Month 6
n=73 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 6.
|
Advanced Prostate Cancer Participants at Month 9
n=56 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had had a value recorded at Month 9.
|
Advanced Prostate Cancer Participants at Month 12
n=109 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 12
|
Advanced Prostate Cancer Participants at Month 15
n=54 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 15.
|
Advanced Prostate Cancer Participants at Month 18
n=64 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 18.
|
Advanced Prostate Cancer Participants at Month 21
n=52 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 21.
|
Advanced Prostate Cancer Participants at Month 24
n=310 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 24.
|
Advanced Prostate Cancer Participants - Last Available Record
n=1411 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had any final value recorded.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Effectiveness Parameter for Staging of Prostate Cancer: Metastases at Each Visit
Single metastases
|
108 participants
|
8 participants
|
3 participants
|
2 participants
|
3 participants
|
2 participants
|
3 participants
|
2 participants
|
15 participants
|
100 participants
|
|
Effectiveness Parameter for Staging of Prostate Cancer: Metastases at Each Visit
Multiple metastases in 1 organ
|
233 participants
|
27 participants
|
18 participants
|
13 participants
|
18 participants
|
13 participants
|
10 participants
|
13 participants
|
63 participants
|
268 participants
|
|
Effectiveness Parameter for Staging of Prostate Cancer: Metastases at Each Visit
Multiple metastases in multiple organs
|
75 participants
|
15 participants
|
4 participants
|
10 participants
|
12 participants
|
5 participants
|
7 participants
|
5 participants
|
34 participants
|
109 participants
|
|
Effectiveness Parameter for Staging of Prostate Cancer: Metastases at Each Visit
Absent
|
782 participants
|
59 participants
|
45 participants
|
28 participants
|
74 participants
|
33 participants
|
44 participants
|
29 participants
|
188 participants
|
870 participants
|
|
Effectiveness Parameter for Staging of Prostate Cancer: Metastases at Each Visit
Local tumor
|
64 participants
|
10 participants
|
3 participants
|
3 participants
|
2 participants
|
1 participants
|
0 participants
|
3 participants
|
10 participants
|
64 participants
|
PRIMARY outcome
Timeframe: time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came firstPopulation: Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data at each visit.
The mean PSA in ng/mL to screen and assess for the recurrence of prostate cancer at each visit is presented.
Outcome measures
| Measure |
Advanced Prostate Cancer Participants at Baseline
n=2532 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at baseline.
|
Advanced Prostate Cancer Participants at Month 3
n=944 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 3.
|
Advanced Prostate Cancer Participants at Month 6
n=787 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 6.
|
Advanced Prostate Cancer Participants at Month 9
n=595 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had had a value recorded at Month 9.
|
Advanced Prostate Cancer Participants at Month 12
n=978 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 12
|
Advanced Prostate Cancer Participants at Month 15
n=493 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 15.
|
Advanced Prostate Cancer Participants at Month 18
n=612 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 18.
|
Advanced Prostate Cancer Participants at Month 21
n=401 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 21.
|
Advanced Prostate Cancer Participants at Month 24
n=1661 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 24.
|
Advanced Prostate Cancer Participants - Last Available Record
n=2595 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had any final value recorded.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Effectiveness Parameter for Screening or Recurrence of Prostate Cancer: Mean Prostate-specific Antigen (PSA) at Each Visit
|
62.16 ng/mL
Standard Deviation 282.64
|
12.95 ng/mL
Standard Deviation 88.03
|
6.23 ng/mL
Standard Deviation 34.27
|
8.01 ng/mL
Standard Deviation 43.28
|
8.41 ng/mL
Standard Deviation 52.84
|
8.88 ng/mL
Standard Deviation 44.66
|
9.57 ng/mL
Standard Deviation 57.42
|
23.02 ng/mL
Standard Deviation 141.92
|
15.29 ng/mL
Standard Deviation 129.06
|
30.32 ng/mL
Standard Deviation 183.21
|
PRIMARY outcome
Timeframe: month 3, and every 3 months until disease progression or up to 24 months, whichever came firstPopulation: Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data at each visit.
Response to treatment is summarized by the number of participants at each visit with a complete or partial response, stable disease, or progressive disease. Disease status determination was not predefined, but was based on the judgement of each Investigator.
Outcome measures
| Measure |
Advanced Prostate Cancer Participants at Baseline
n=1038 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at baseline.
|
Advanced Prostate Cancer Participants at Month 3
n=853 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 3.
|
Advanced Prostate Cancer Participants at Month 6
n=670 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 6.
|
Advanced Prostate Cancer Participants at Month 9
n=1031 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had had a value recorded at Month 9.
|
Advanced Prostate Cancer Participants at Month 12
n=565 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 12
|
Advanced Prostate Cancer Participants at Month 15
n=679 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 15.
|
Advanced Prostate Cancer Participants at Month 18
n=475 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 18.
|
Advanced Prostate Cancer Participants at Month 21
n=1764 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 21.
|
Advanced Prostate Cancer Participants at Month 24
n=2210 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 24.
|
Advanced Prostate Cancer Participants - Last Available Record
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had any final value recorded.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Effectiveness Parameter: the Number of Participants With a Complete or Partial Response, Stable Disease, or Progressive Disease Following Treatment at Each Visit
Complete response
|
525 participants
|
496 participants
|
402 participants
|
668 participants
|
347 participants
|
401 participants
|
276 participants
|
1181 participants
|
1420 participants
|
—
|
|
Effectiveness Parameter: the Number of Participants With a Complete or Partial Response, Stable Disease, or Progressive Disease Following Treatment at Each Visit
Partial response
|
379 participants
|
231 participants
|
139 participants
|
181 participants
|
97 participants
|
98 participants
|
59 participants
|
199 participants
|
284 participants
|
—
|
|
Effectiveness Parameter: the Number of Participants With a Complete or Partial Response, Stable Disease, or Progressive Disease Following Treatment at Each Visit
Stable disease
|
97 participants
|
89 participants
|
83 participants
|
97 participants
|
69 participants
|
102 participants
|
73 participants
|
200 participants
|
224 participants
|
—
|
|
Effectiveness Parameter: the Number of Participants With a Complete or Partial Response, Stable Disease, or Progressive Disease Following Treatment at Each Visit
Progressive disease
|
37 participants
|
37 participants
|
46 participants
|
85 participants
|
52 participants
|
78 participants
|
67 participants
|
184 participants
|
282 participants
|
—
|
PRIMARY outcome
Timeframe: time 0 (Baseline), month 3, and every 3 months thereafter until disease progression or up to 24 months, whichever came firstPopulation: Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data at each visit.
The prognosis for participants is summarized for each visit by the number of participants at each visit with a survival prognosis of 10 years, 5 - 10 years, 1 - 5 years, 6 - 12 months, and \< 6 months. Methods for determining survival prognosis were not prespecified, but were based on the judgement of each Investigator.
Outcome measures
| Measure |
Advanced Prostate Cancer Participants at Baseline
n=2128 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at baseline.
|
Advanced Prostate Cancer Participants at Month 3
n=941 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 3.
|
Advanced Prostate Cancer Participants at Month 6
n=752 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 6.
|
Advanced Prostate Cancer Participants at Month 9
n=604 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had had a value recorded at Month 9.
|
Advanced Prostate Cancer Participants at Month 12
n=881 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 12
|
Advanced Prostate Cancer Participants at Month 15
n=509 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 15.
|
Advanced Prostate Cancer Participants at Month 18
n=593 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 18.
|
Advanced Prostate Cancer Participants at Month 21
n=426 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 21.
|
Advanced Prostate Cancer Participants at Month 24
n=1495 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 24.
|
Advanced Prostate Cancer Participants - Last Available Record
n=2365 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had any final value recorded.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Effectiveness Parameter for Prognosis: the Number of Participants With a Survival Prognosis of > 10 Years, 5 - 10 Years, 1 - 5 Years, 6 - 12 Months, and < 6 Months
> 10 years
|
395 participants
|
132 participants
|
100 participants
|
91 participants
|
113 participants
|
75 participants
|
82 participants
|
66 participants
|
206 participants
|
331 participants
|
|
Effectiveness Parameter for Prognosis: the Number of Participants With a Survival Prognosis of > 10 Years, 5 - 10 Years, 1 - 5 Years, 6 - 12 Months, and < 6 Months
5 - 10 years
|
1041 participants
|
476 participants
|
402 participants
|
320 participants
|
479 participants
|
276 participants
|
309 participants
|
225 participants
|
805 participants
|
1173 participants
|
|
Effectiveness Parameter for Prognosis: the Number of Participants With a Survival Prognosis of > 10 Years, 5 - 10 Years, 1 - 5 Years, 6 - 12 Months, and < 6 Months
1 - 5 years
|
663 participants
|
312 participants
|
237 participants
|
180 participants
|
268 participants
|
140 participants
|
182 participants
|
117 participants
|
420 participants
|
735 participants
|
|
Effectiveness Parameter for Prognosis: the Number of Participants With a Survival Prognosis of > 10 Years, 5 - 10 Years, 1 - 5 Years, 6 - 12 Months, and < 6 Months
6 - 12 months
|
26 participants
|
15 participants
|
10 participants
|
11 participants
|
18 participants
|
15 participants
|
13 participants
|
12 participants
|
48 participants
|
93 participants
|
|
Effectiveness Parameter for Prognosis: the Number of Participants With a Survival Prognosis of > 10 Years, 5 - 10 Years, 1 - 5 Years, 6 - 12 Months, and < 6 Months
< 6 months
|
3 participants
|
6 participants
|
3 participants
|
2 participants
|
3 participants
|
3 participants
|
7 participants
|
6 participants
|
16 participants
|
33 participants
|
PRIMARY outcome
Timeframe: time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came firstPopulation: Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data at each visit.
Prostate cancer treatment for all participants is summarized by the number of participants at each visit who took any Lucrin/Lucrin Tridepot, LHRH agonist, anti-androgens, or other drug treatments, or who had any type of surgery or radiotherapy (external radiation or brachytherapy).
Outcome measures
| Measure |
Advanced Prostate Cancer Participants at Baseline
n=2714 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at baseline.
|
Advanced Prostate Cancer Participants at Month 3
n=1134 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 3.
|
Advanced Prostate Cancer Participants at Month 6
n=907 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 6.
|
Advanced Prostate Cancer Participants at Month 9
n=715 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had had a value recorded at Month 9.
|
Advanced Prostate Cancer Participants at Month 12
n=1082 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 12
|
Advanced Prostate Cancer Participants at Month 15
n=611 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 15.
|
Advanced Prostate Cancer Participants at Month 18
n=717 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 18.
|
Advanced Prostate Cancer Participants at Month 21
n=513 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 21.
|
Advanced Prostate Cancer Participants at Month 24
n=1954 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 24.
|
Advanced Prostate Cancer Participants - Last Available Record
n=2714 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had any final value recorded.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Treatment Patterns for Prostate Cancer Treatments: Number of Participants at Each Visit Who Took Lucrin/Lucrin Tridepot, Luteinizing Hormone-releasing Hormone (LHRH) Agonists, Anti-androgens, or Other Drug Treatments, or Who Had Surgery or Radiotherapy.
Any anti-androgen treatments used at each visit
|
841 participants
|
388 participants
|
303 participants
|
243 participants
|
397 participants
|
223 participants
|
261 participants
|
182 participants
|
603 participants
|
1021 participants
|
|
Treatment Patterns for Prostate Cancer Treatments: Number of Participants at Each Visit Who Took Lucrin/Lucrin Tridepot, Luteinizing Hormone-releasing Hormone (LHRH) Agonists, Anti-androgens, or Other Drug Treatments, or Who Had Surgery or Radiotherapy.
Any Lucrin or Lucrin Tridepot used at each visit
|
2028 participants
|
1011 participants
|
817 participants
|
640 participants
|
969 participants
|
540 participants
|
629 participants
|
450 participants
|
1628 participants
|
2384 participants
|
|
Treatment Patterns for Prostate Cancer Treatments: Number of Participants at Each Visit Who Took Lucrin/Lucrin Tridepot, Luteinizing Hormone-releasing Hormone (LHRH) Agonists, Anti-androgens, or Other Drug Treatments, or Who Had Surgery or Radiotherapy.
Any LHRH agonist treatments used at each visit
|
2034 participants
|
1015 participants
|
821 participants
|
643 participants
|
973 participants
|
545 participants
|
636 participants
|
452 participants
|
1635 participants
|
2392 participants
|
|
Treatment Patterns for Prostate Cancer Treatments: Number of Participants at Each Visit Who Took Lucrin/Lucrin Tridepot, Luteinizing Hormone-releasing Hormone (LHRH) Agonists, Anti-androgens, or Other Drug Treatments, or Who Had Surgery or Radiotherapy.
Other drug treatments used at each visit
|
31 participants
|
22 participants
|
21 participants
|
24 participants
|
31 participants
|
27 participants
|
24 participants
|
23 participants
|
57 participants
|
86 participants
|
|
Treatment Patterns for Prostate Cancer Treatments: Number of Participants at Each Visit Who Took Lucrin/Lucrin Tridepot, Luteinizing Hormone-releasing Hormone (LHRH) Agonists, Anti-androgens, or Other Drug Treatments, or Who Had Surgery or Radiotherapy.
Any surgery performed any time up to the visit
|
244 participants
|
145 participants
|
103 participants
|
97 participants
|
127 participants
|
92 participants
|
94 participants
|
80 participants
|
192 participants
|
281 participants
|
|
Treatment Patterns for Prostate Cancer Treatments: Number of Participants at Each Visit Who Took Lucrin/Lucrin Tridepot, Luteinizing Hormone-releasing Hormone (LHRH) Agonists, Anti-androgens, or Other Drug Treatments, or Who Had Surgery or Radiotherapy.
External radiation performed any time up to visit
|
129 participants
|
84 participants
|
76 participants
|
73 participants
|
79 participants
|
43 participants
|
56 participants
|
33 participants
|
133 participants
|
228 participants
|
|
Treatment Patterns for Prostate Cancer Treatments: Number of Participants at Each Visit Who Took Lucrin/Lucrin Tridepot, Luteinizing Hormone-releasing Hormone (LHRH) Agonists, Anti-androgens, or Other Drug Treatments, or Who Had Surgery or Radiotherapy.
Brachytherapy performed any time up to the visit
|
13 participants
|
10 participants
|
10 participants
|
11 participants
|
10 participants
|
9 participants
|
9 participants
|
8 participants
|
21 participants
|
26 participants
|
SECONDARY outcome
Timeframe: Baseline to disease progression or 24 months, whichever came firstPopulation: Analysis was performed on the full analysis set consisting of all patients for whom at least baseline data were recorded.
The number of participants experiencing a serious adverse event during the course of the study is summarized. See the Reported Adverse Event section for details.
Outcome measures
| Measure |
Advanced Prostate Cancer Participants at Baseline
n=2714 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at baseline.
|
Advanced Prostate Cancer Participants at Month 3
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 3.
|
Advanced Prostate Cancer Participants at Month 6
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 6.
|
Advanced Prostate Cancer Participants at Month 9
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had had a value recorded at Month 9.
|
Advanced Prostate Cancer Participants at Month 12
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 12
|
Advanced Prostate Cancer Participants at Month 15
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 15.
|
Advanced Prostate Cancer Participants at Month 18
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 18.
|
Advanced Prostate Cancer Participants at Month 21
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 21.
|
Advanced Prostate Cancer Participants at Month 24
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 24.
|
Advanced Prostate Cancer Participants - Last Available Record
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had any final value recorded.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Safety Parameter: Number of Participants Reporting Serious Adverse Events (SAEs)
|
121 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at time 0 (Baseline)Population: Analysis was performed on the full analysis set consisting of all patients for whom at least baseline data were recorded. Data for age was available for 2,691 patients and for weight for 2,116 patients.
The mean weight of all participants at baseline is provided.
Outcome measures
| Measure |
Advanced Prostate Cancer Participants at Baseline
n=2714 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at baseline.
|
Advanced Prostate Cancer Participants at Month 3
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 3.
|
Advanced Prostate Cancer Participants at Month 6
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 6.
|
Advanced Prostate Cancer Participants at Month 9
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had had a value recorded at Month 9.
|
Advanced Prostate Cancer Participants at Month 12
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 12
|
Advanced Prostate Cancer Participants at Month 15
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 15.
|
Advanced Prostate Cancer Participants at Month 18
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 18.
|
Advanced Prostate Cancer Participants at Month 21
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 21.
|
Advanced Prostate Cancer Participants at Month 24
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 24.
|
Advanced Prostate Cancer Participants - Last Available Record
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had any final value recorded.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Epidemiological Data: Mean Weight
|
77.36 kg
Standard Deviation 10.48
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at time 0 (Baseline)Population: Analysis was performed on the full analysis set consisting of all patients for whom at least baseline data were recorded. Data for age was available for 2,691 patients and for weight for 2,116 patients.
The mean age of all participants at baseline is provided.
Outcome measures
| Measure |
Advanced Prostate Cancer Participants at Baseline
n=2714 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at baseline.
|
Advanced Prostate Cancer Participants at Month 3
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 3.
|
Advanced Prostate Cancer Participants at Month 6
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 6.
|
Advanced Prostate Cancer Participants at Month 9
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had had a value recorded at Month 9.
|
Advanced Prostate Cancer Participants at Month 12
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 12
|
Advanced Prostate Cancer Participants at Month 15
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 15.
|
Advanced Prostate Cancer Participants at Month 18
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 18.
|
Advanced Prostate Cancer Participants at Month 21
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 21.
|
Advanced Prostate Cancer Participants at Month 24
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 24.
|
Advanced Prostate Cancer Participants - Last Available Record
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had any final value recorded.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Epidemiological Data: Mean Age
|
75.39 years
Standard Deviation 7.92
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at time 0 (Baseline)Population: Analysis was performed on the full analysis set consisting of all patients for whom at least baseline data were recorded. Data for race was available for 2,217 patients.
The number of participants by race at baseline is presented.
Outcome measures
| Measure |
Advanced Prostate Cancer Participants at Baseline
n=2217 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at baseline.
|
Advanced Prostate Cancer Participants at Month 3
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 3.
|
Advanced Prostate Cancer Participants at Month 6
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 6.
|
Advanced Prostate Cancer Participants at Month 9
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had had a value recorded at Month 9.
|
Advanced Prostate Cancer Participants at Month 12
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 12
|
Advanced Prostate Cancer Participants at Month 15
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 15.
|
Advanced Prostate Cancer Participants at Month 18
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 18.
|
Advanced Prostate Cancer Participants at Month 21
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 21.
|
Advanced Prostate Cancer Participants at Month 24
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 24.
|
Advanced Prostate Cancer Participants - Last Available Record
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had any final value recorded.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Epidemiological Data: Race
Black
|
59 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Epidemiological Data: Race
Caucasian
|
2154 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Epidemiological Data: Race
Other
|
4 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at time 0 (Baseline)Population: Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data.
Among those participants with a positive biopsy at baseline, the number of participants with adenocarcinoma tissue or other tissue type is summarized.
Outcome measures
| Measure |
Advanced Prostate Cancer Participants at Baseline
n=2279 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at baseline.
|
Advanced Prostate Cancer Participants at Month 3
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 3.
|
Advanced Prostate Cancer Participants at Month 6
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 6.
|
Advanced Prostate Cancer Participants at Month 9
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had had a value recorded at Month 9.
|
Advanced Prostate Cancer Participants at Month 12
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 12
|
Advanced Prostate Cancer Participants at Month 15
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 15.
|
Advanced Prostate Cancer Participants at Month 18
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 18.
|
Advanced Prostate Cancer Participants at Month 21
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 21.
|
Advanced Prostate Cancer Participants at Month 24
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 24.
|
Advanced Prostate Cancer Participants - Last Available Record
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had any final value recorded.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Epidemiological Data: Tumor Staging - Among Participants With a Positive Biopsy, the Number of Participants With Adenocarcinoma Tissue or Other Tissues Recorded for the Positive Biopsy.
Adenocarcinoma
|
2269 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Epidemiological Data: Tumor Staging - Among Participants With a Positive Biopsy, the Number of Participants With Adenocarcinoma Tissue or Other Tissues Recorded for the Positive Biopsy.
Other
|
9 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Epidemiological Data: Tumor Staging - Among Participants With a Positive Biopsy, the Number of Participants With Adenocarcinoma Tissue or Other Tissues Recorded for the Positive Biopsy.
Not done
|
1 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at time 0 (Baseline)Population: Analysis was performed on the full analysis set consisting of all patients for whom at least baseline data were recorded. Data for PSA at baseline was available for 2,532 patients.
The median, minimum, and maximum PSA values in ng/mL at baseline are provided. The mean PSA at baseline is reported in the Primary Outcome Measure section above.
Outcome measures
| Measure |
Advanced Prostate Cancer Participants at Baseline
n=2532 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at baseline.
|
Advanced Prostate Cancer Participants at Month 3
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 3.
|
Advanced Prostate Cancer Participants at Month 6
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 6.
|
Advanced Prostate Cancer Participants at Month 9
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had had a value recorded at Month 9.
|
Advanced Prostate Cancer Participants at Month 12
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 12
|
Advanced Prostate Cancer Participants at Month 15
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 15.
|
Advanced Prostate Cancer Participants at Month 18
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 18.
|
Advanced Prostate Cancer Participants at Month 21
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 21.
|
Advanced Prostate Cancer Participants at Month 24
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 24.
|
Advanced Prostate Cancer Participants - Last Available Record
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had any final value recorded.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Epidemiological Data: PSA at Baseline
|
13.66 ng/mL
Interval 0.0 to 6500.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at time 0 (Baseline)Population: Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data.
The number of participants at baseline who were positive or negative for tumors via a rectal examination, prostate biopsy, echograph of the hyperechogenic zones, or MRI are provided.
Outcome measures
| Measure |
Advanced Prostate Cancer Participants at Baseline
n=2484 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at baseline.
|
Advanced Prostate Cancer Participants at Month 3
n=2364 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 3.
|
Advanced Prostate Cancer Participants at Month 6
n=2252 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 6.
|
Advanced Prostate Cancer Participants at Month 9
n=187 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had had a value recorded at Month 9.
|
Advanced Prostate Cancer Participants at Month 12
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 12
|
Advanced Prostate Cancer Participants at Month 15
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 15.
|
Advanced Prostate Cancer Participants at Month 18
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 18.
|
Advanced Prostate Cancer Participants at Month 21
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 21.
|
Advanced Prostate Cancer Participants at Month 24
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 24.
|
Advanced Prostate Cancer Participants - Last Available Record
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had any final value recorded.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Epidemiological Data: Tumor Staging (Positive or Negative) Via a Rectal Examination, Prostate Biopsy, Echograph, or Magnetic Resonance Imaging (MRI) Test.
Negative at baseline
|
439 participants
|
9 participants
|
446 participants
|
85 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Epidemiological Data: Tumor Staging (Positive or Negative) Via a Rectal Examination, Prostate Biopsy, Echograph, or Magnetic Resonance Imaging (MRI) Test.
Positive at baseline
|
2045 participants
|
2355 participants
|
1806 participants
|
102 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at time 0 (Baseline)Population: Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data.
The number of participants with tumor stages T0, T1, T2, T3, and T4 as reported by the physician or pathologist is summarized. T0: no evidence of primary tumor. T1: histologic tumor confined to prostate; clinically unapparent tumor, undetectable by digital rectal examination or by ultrasound. T2: tumor is confined to prostrate and can be detected by digital rectal examination. T3: tumor extends through the prostate capsule but has not spread to other organs. T4: tumor has invaded adjacent structures/organs other than seminal vesicles.
Outcome measures
| Measure |
Advanced Prostate Cancer Participants at Baseline
n=2302 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at baseline.
|
Advanced Prostate Cancer Participants at Month 3
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 3.
|
Advanced Prostate Cancer Participants at Month 6
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 6.
|
Advanced Prostate Cancer Participants at Month 9
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had had a value recorded at Month 9.
|
Advanced Prostate Cancer Participants at Month 12
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 12
|
Advanced Prostate Cancer Participants at Month 15
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 15.
|
Advanced Prostate Cancer Participants at Month 18
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 18.
|
Advanced Prostate Cancer Participants at Month 21
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 21.
|
Advanced Prostate Cancer Participants at Month 24
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 24.
|
Advanced Prostate Cancer Participants - Last Available Record
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had any final value recorded.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Epidemiological Data: the Number of Participants With Tumor Stages T0, T1, T2, T3, and T4.
T3 stage
|
1215 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Epidemiological Data: the Number of Participants With Tumor Stages T0, T1, T2, T3, and T4.
T0 stage
|
30 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Epidemiological Data: the Number of Participants With Tumor Stages T0, T1, T2, T3, and T4.
T1 stage
|
223 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Epidemiological Data: the Number of Participants With Tumor Stages T0, T1, T2, T3, and T4.
T2 stage
|
614 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Epidemiological Data: the Number of Participants With Tumor Stages T0, T1, T2, T3, and T4.
T4 stage
|
220 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at time 0 (Baseline)Population: Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data.
In this case, a CT or MRI is considered positive when lymph nodes are detectable. A CT or MRI is considered negative when lymph nodes are not detectable.
Outcome measures
| Measure |
Advanced Prostate Cancer Participants at Baseline
n=1586 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at baseline.
|
Advanced Prostate Cancer Participants at Month 3
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 3.
|
Advanced Prostate Cancer Participants at Month 6
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 6.
|
Advanced Prostate Cancer Participants at Month 9
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had had a value recorded at Month 9.
|
Advanced Prostate Cancer Participants at Month 12
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 12
|
Advanced Prostate Cancer Participants at Month 15
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 15.
|
Advanced Prostate Cancer Participants at Month 18
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 18.
|
Advanced Prostate Cancer Participants at Month 21
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 21.
|
Advanced Prostate Cancer Participants at Month 24
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 24.
|
Advanced Prostate Cancer Participants - Last Available Record
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had any final value recorded.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Epidemiological Data: Node Staging - the Number of Participants With a Positive or Negative Computerized Tomography (CT) Scan or Magnetic Resonance Imaging (MRI) Test
Positive at baseline
|
374 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Epidemiological Data: Node Staging - the Number of Participants With a Positive or Negative Computerized Tomography (CT) Scan or Magnetic Resonance Imaging (MRI) Test
Negative at baseline
|
1212 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at time 0 (Baseline)Population: Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data.
N0: tumor cells absent from regional lymph nodes. N1: regional lymph node metastasis present.
Outcome measures
| Measure |
Advanced Prostate Cancer Participants at Baseline
n=1656 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at baseline.
|
Advanced Prostate Cancer Participants at Month 3
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 3.
|
Advanced Prostate Cancer Participants at Month 6
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 6.
|
Advanced Prostate Cancer Participants at Month 9
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had had a value recorded at Month 9.
|
Advanced Prostate Cancer Participants at Month 12
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 12
|
Advanced Prostate Cancer Participants at Month 15
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 15.
|
Advanced Prostate Cancer Participants at Month 18
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 18.
|
Advanced Prostate Cancer Participants at Month 21
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 21.
|
Advanced Prostate Cancer Participants at Month 24
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 24.
|
Advanced Prostate Cancer Participants - Last Available Record
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had any final value recorded.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Epidemiological Data: Node Staging - the Number of Participants With a N0 or N1 Stage at Baseline.
N0 stage
|
1296 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Epidemiological Data: Node Staging - the Number of Participants With a N0 or N1 Stage at Baseline.
N1 stage
|
360 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at time 0 (Baseline)Population: Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data.
The number of participants at baseline with a positive or negative bone scan was summarized. Determination of bone scan status was based on the interpretation of the Investigator or radiologist.
Outcome measures
| Measure |
Advanced Prostate Cancer Participants at Baseline
n=1850 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at baseline.
|
Advanced Prostate Cancer Participants at Month 3
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 3.
|
Advanced Prostate Cancer Participants at Month 6
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 6.
|
Advanced Prostate Cancer Participants at Month 9
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had had a value recorded at Month 9.
|
Advanced Prostate Cancer Participants at Month 12
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 12
|
Advanced Prostate Cancer Participants at Month 15
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 15.
|
Advanced Prostate Cancer Participants at Month 18
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 18.
|
Advanced Prostate Cancer Participants at Month 21
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 21.
|
Advanced Prostate Cancer Participants at Month 24
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 24.
|
Advanced Prostate Cancer Participants - Last Available Record
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had any final value recorded.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Epidemiological Data: Bone Scan at Baseline
Positive at baseline
|
497 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Epidemiological Data: Bone Scan at Baseline
Negative at baseline
|
1353 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at time 0 (Baseline)Population: Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data.
The number of participants at baseline reported to be in metastasis stage M0 or M1 is summarized. M0: no distant metastasis. M1: metastasis to distant organs beyond regional lymph nodes.
Outcome measures
| Measure |
Advanced Prostate Cancer Participants at Baseline
n=1874 Participants
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at baseline.
|
Advanced Prostate Cancer Participants at Month 3
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 3.
|
Advanced Prostate Cancer Participants at Month 6
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 6.
|
Advanced Prostate Cancer Participants at Month 9
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had had a value recorded at Month 9.
|
Advanced Prostate Cancer Participants at Month 12
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 12
|
Advanced Prostate Cancer Participants at Month 15
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 15.
|
Advanced Prostate Cancer Participants at Month 18
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 18.
|
Advanced Prostate Cancer Participants at Month 21
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 21.
|
Advanced Prostate Cancer Participants at Month 24
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 24.
|
Advanced Prostate Cancer Participants - Last Available Record
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had any final value recorded.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Epidemiological Data: Metastasis Staging (M0 or M1) at Baseline
M0 stage
|
1373 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Epidemiological Data: Metastasis Staging (M0 or M1) at Baseline
M1 stage
|
501 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Advanced Prostate Cancer Participants
Serious events: 121 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Advanced Prostate Cancer Participants
n=2714 participants at risk
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Cardiac disorders
Atrial fibrillation
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Cardiac disorders
Cardiac arrest
|
0.15%
4/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Cardiac disorders
Cardiac disorder
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Cardiac disorders
Cardiac failure
|
0.37%
10/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Cardiac disorders
Cardiogenic shock
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Cardiac disorders
Cardiomyopathy
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.07%
2/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Cardiac disorders
Cardiovascular disorder
|
0.07%
2/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Cardiac disorders
Myocardial infarction
|
0.26%
7/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Gastrointestinal disorders
Dysphagia
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Gastrointestinal disorders
Peritonitis
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
General disorders
Death
|
0.29%
8/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
General disorders
Disease progression
|
0.26%
7/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
General disorders
Fatigue
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
General disorders
General physical health deterioration
|
0.15%
4/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
General disorders
Multi-organ failure
|
0.07%
2/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
General disorders
Terminal state
|
0.07%
2/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
General disorders
Therapeutic response decreased
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Infections and infestations
Bronchitis
|
0.07%
2/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Infections and infestations
Bronchopneumonia
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Infections and infestations
Lung infection
|
0.07%
2/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Infections and infestations
Pneumonia
|
0.18%
5/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Infections and infestations
Pulmonary sepsis
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Infections and infestations
Sepsis
|
0.15%
4/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Infections and infestations
Superinfection
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Injury, poisoning and procedural complications
Accident
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Investigations
Cardiac enzymes increased
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Investigations
Prostatic specific antigen abnormal
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.07%
2/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.07%
2/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Metabolism and nutrition disorders
Diet refusal
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Musculoskeletal and connective tissue disorders
Bone disorder
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer male
|
0.07%
2/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.07%
2/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.11%
3/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bladder
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.41%
11/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.18%
5/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.11%
3/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.11%
3/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.18%
5/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.07%
2/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.07%
2/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.88%
24/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.18%
5/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell carcinoma
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ureteral neoplasm
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Nervous system disorders
Coma
|
0.07%
2/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Nervous system disorders
Dementia
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Nervous system disorders
Headache
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Nervous system disorders
Parkinson's disease
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Nervous system disorders
Thrombotic stroke
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Psychiatric disorders
Depression
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Renal and urinary disorders
Anuria
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Renal and urinary disorders
Azotaemia
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Renal and urinary disorders
Dysuria
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Renal and urinary disorders
Renal failure
|
0.07%
2/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Renal and urinary disorders
Renal failure acute
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.07%
2/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.07%
2/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.07%
2/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.15%
4/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Surgical and medical procedures
Bladder catheterisation
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Surgical and medical procedures
Cardiac operation
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Vascular disorders
Angiopathy
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Vascular disorders
Embolism
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Vascular disorders
Infarction
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Vascular disorders
Thrombophlebitis
|
0.04%
1/2714 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
Other adverse events
| Measure |
Advanced Prostate Cancer Participants
n=2714 participants at risk
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
|
|---|---|
|
Congenital, familial and genetic disorders
Porphyria non-acute
|
0.04%
1/2714 • Number of events 1 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
General disorders
Fatigue
|
0.04%
1/2714 • Number of events 1 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.04%
1/2714 • Number of events 1 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Nervous system disorders
Syncope
|
0.04%
1/2714 • Number of events 1 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Renal and urinary disorders
Urinary retention
|
0.04%
1/2714 • Number of events 1 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.04%
1/2714 • Number of events 1 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
|
Vascular disorders
Hot flush
|
0.07%
2/2714 • Number of events 2 • All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
|
Additional Information
Global Medical Services
Abbott
Phone: 800-633-9110
Results disclosure agreements
- Principal investigator is a sponsor employee Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER