Trial Outcomes & Findings for S1216, Phase III ADT+TAK-700 vs. ADT+Bicalutamide for Metastatic Prostate Cancer (NCT NCT01809691)
NCT ID: NCT01809691
Last Updated: 2025-12-31
Results Overview
Overall survival is defined as the time from random assignment to the date of death from any cause
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1313 participants
Primary outcome timeframe
Duration of treatment and follow-up until death or 9 years after study start
Results posted on
2025-12-31
Participant Flow
1,313 participants were enrolled and randomly assigned. 32 participants were deemed ineligible and 2 withdrew consent before starting treatment. Therefore, 1,279 were deemed eligible and analyzable for the primary analysis.
Participant milestones
| Measure |
LHRHa + TAK-700
Experimental: ADT + TAK-700 LHRH agonist - given as approved for androgen deprivation at a dose necessary to maintain castrate levels and equivalent to 22.5 mg of Leuprolide IM every 3 months.
TAK-700, 300 mg, PO, twice daily
|
LHRHa + Bicalutamide
Active Comparator: ADT + Bicalutamide LHRH agonist - given as approved for androgen deprivation at a dose necessary to maintain castrate levels and equivalent to 22.5 mg of Leuprolide IM every 3 months.
Bicalutamide, 50 mg, PO, q daily
|
|---|---|---|
|
Overall Study
STARTED
|
638
|
641
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
638
|
641
|
Reasons for withdrawal
| Measure |
LHRHa + TAK-700
Experimental: ADT + TAK-700 LHRH agonist - given as approved for androgen deprivation at a dose necessary to maintain castrate levels and equivalent to 22.5 mg of Leuprolide IM every 3 months.
TAK-700, 300 mg, PO, twice daily
|
LHRHa + Bicalutamide
Active Comparator: ADT + Bicalutamide LHRH agonist - given as approved for androgen deprivation at a dose necessary to maintain castrate levels and equivalent to 22.5 mg of Leuprolide IM every 3 months.
Bicalutamide, 50 mg, PO, q daily
|
|---|---|---|
|
Overall Study
Currently on Treatment
|
192
|
100
|
|
Overall Study
No Protocol Treatment
|
10
|
11
|
|
Overall Study
Adverse Event
|
80
|
21
|
|
Overall Study
Disease Progression
|
226
|
372
|
|
Overall Study
Death
|
26
|
13
|
|
Overall Study
Participant Refusal
|
70
|
72
|
|
Overall Study
Other, Not Specified
|
34
|
52
|
Baseline Characteristics
S1216, Phase III ADT+TAK-700 vs. ADT+Bicalutamide for Metastatic Prostate Cancer
Baseline characteristics by cohort
| Measure |
LHRHa + TAK-700
n=638 Participants
Experimental: ADT + TAK-700 LHRH agonist - given as approved for androgen deprivation at a dose necessary to maintain castrate levels and equivalent to 22.5 mg of Leuprolide IM every 3 months.
TAK-700, 300 mg, PO, twice daily
|
LHRHa + Bicalutamide
n=641 Participants
Active Comparator: ADT + Bicalutamide LHRH agonist - given as approved for androgen deprivation at a dose necessary to maintain castrate levels and equivalent to 22.5 mg of Leuprolide IM every 3 months.
Bicalutamide, 50 mg, PO, q daily
|
Total
n=1279 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.6 years
n=1000 Participants
|
68.1 years
n=1986 Participants
|
67.8 years
n=2008 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
|
Sex: Female, Male
Male
|
638 Participants
n=1000 Participants
|
641 Participants
n=1986 Participants
|
1279 Participants
n=2008 Participants
|
|
Race/Ethnicity, Customized
White
|
539 Participants
n=1000 Participants
|
538 Participants
n=1986 Participants
|
1077 Participants
n=2008 Participants
|
|
Race/Ethnicity, Customized
Black
|
64 Participants
n=1000 Participants
|
71 Participants
n=1986 Participants
|
135 Participants
n=2008 Participants
|
|
Race/Ethnicity, Customized
Others
|
35 Participants
n=1000 Participants
|
32 Participants
n=1986 Participants
|
67 Participants
n=2008 Participants
|
|
Zubrod Performance Status Score
0
|
416 Participants
n=1000 Participants
|
442 Participants
n=1986 Participants
|
858 Participants
n=2008 Participants
|
|
Zubrod Performance Status Score
1
|
197 Participants
n=1000 Participants
|
175 Participants
n=1986 Participants
|
372 Participants
n=2008 Participants
|
|
Zubrod Performance Status Score
2
|
21 Participants
n=1000 Participants
|
21 Participants
n=1986 Participants
|
42 Participants
n=2008 Participants
|
|
Zubrod Performance Status Score
3
|
3 Participants
n=1000 Participants
|
2 Participants
n=1986 Participants
|
5 Participants
n=2008 Participants
|
|
Zubrod Performance Status Score
Missing
|
1 Participants
n=1000 Participants
|
1 Participants
n=1986 Participants
|
2 Participants
n=2008 Participants
|
|
Gleason Score at Initial Diagnosis
< 7
|
46 Participants
n=1000 Participants
|
39 Participants
n=1986 Participants
|
85 Participants
n=2008 Participants
|
|
Gleason Score at Initial Diagnosis
7
|
165 Participants
n=1000 Participants
|
168 Participants
n=1986 Participants
|
333 Participants
n=2008 Participants
|
|
Gleason Score at Initial Diagnosis
8
|
123 Participants
n=1000 Participants
|
118 Participants
n=1986 Participants
|
241 Participants
n=2008 Participants
|
|
Gleason Score at Initial Diagnosis
9-10
|
249 Participants
n=1000 Participants
|
264 Participants
n=1986 Participants
|
513 Participants
n=2008 Participants
|
|
Gleason Score at Initial Diagnosis
Missing
|
55 Participants
n=1000 Participants
|
52 Participants
n=1986 Participants
|
107 Participants
n=2008 Participants
|
|
Median PSA Level
|
27.2 ng/mL
n=1000 Participants
|
31.8 ng/mL
n=1986 Participants
|
29.7 ng/mL
n=2008 Participants
|
|
Bone Pain
Yes
|
158 Participants
n=1000 Participants
|
143 Participants
n=1986 Participants
|
301 Participants
n=2008 Participants
|
|
Bone Pain
No
|
480 Participants
n=1000 Participants
|
498 Participants
n=1986 Participants
|
978 Participants
n=2008 Participants
|
|
Bone Metastases
Yes
|
470 Participants
n=1000 Participants
|
482 Participants
n=1986 Participants
|
952 Participants
n=2008 Participants
|
|
Bone Metastases
No
|
168 Participants
n=1000 Participants
|
159 Participants
n=1986 Participants
|
327 Participants
n=2008 Participants
|
|
Liver Metastases
Yes
|
16 Participants
n=1000 Participants
|
14 Participants
n=1986 Participants
|
30 Participants
n=2008 Participants
|
|
Liver Metastases
No
|
622 Participants
n=1000 Participants
|
627 Participants
n=1986 Participants
|
1249 Participants
n=2008 Participants
|
|
Other Visceral Metastases
Yes
|
82 Participants
n=1000 Participants
|
72 Participants
n=1986 Participants
|
154 Participants
n=2008 Participants
|
|
Other Visceral Metastases
No
|
556 Participants
n=1000 Participants
|
569 Participants
n=1986 Participants
|
1125 Participants
n=2008 Participants
|
|
Disease Severity
Minimal
|
328 Participants
n=1000 Participants
|
328 Participants
n=1986 Participants
|
656 Participants
n=2008 Participants
|
|
Disease Severity
Extensive
|
310 Participants
n=1000 Participants
|
313 Participants
n=1986 Participants
|
623 Participants
n=2008 Participants
|
|
Preregistration LHRH Suppression
Yes
|
330 Participants
n=1000 Participants
|
331 Participants
n=1986 Participants
|
661 Participants
n=2008 Participants
|
|
Preregistration LHRH Suppression
No
|
308 Participants
n=1000 Participants
|
310 Participants
n=1986 Participants
|
618 Participants
n=2008 Participants
|
|
Bisphosphonate Use at Study Entry
Yes
|
39 Participants
n=1000 Participants
|
35 Participants
n=1986 Participants
|
74 Participants
n=2008 Participants
|
|
Bisphosphonate Use at Study Entry
No
|
599 Participants
n=1000 Participants
|
606 Participants
n=1986 Participants
|
1205 Participants
n=2008 Participants
|
|
Prior Radical Prostatectomy
Yes
|
167 Participants
n=1000 Participants
|
148 Participants
n=1986 Participants
|
315 Participants
n=2008 Participants
|
|
Prior Radical Prostatectomy
No
|
471 Participants
n=1000 Participants
|
493 Participants
n=1986 Participants
|
964 Participants
n=2008 Participants
|
|
Prior Bilateral Orchiectomy
Yes
|
4 Participants
n=1000 Participants
|
3 Participants
n=1986 Participants
|
7 Participants
n=2008 Participants
|
|
Prior Bilateral Orchiectomy
No
|
634 Participants
n=1000 Participants
|
638 Participants
n=1986 Participants
|
1272 Participants
n=2008 Participants
|
PRIMARY outcome
Timeframe: Duration of treatment and follow-up until death or 9 years after study startOverall survival is defined as the time from random assignment to the date of death from any cause
Outcome measures
| Measure |
LHRHa + TAK-700
n=638 Participants
Experimental: ADT + TAK-700 LHRH agonist - given as approved for androgen deprivation at a dose necessary to maintain castrate levels and equivalent to 22.5 mg of Leuprolide IM every 3 months.
TAK-700, 300 mg, PO, twice daily
|
LHRHa + Bicalutamide
n=641 Participants
Active Comparator: ADT + Bicalutamide LHRH agonist - given as approved for androgen deprivation at a dose necessary to maintain castrate levels and equivalent to 22.5 mg of Leuprolide IM every 3 months.
Bicalutamide, 50 mg, PO, q daily
|
|---|---|---|
|
Overall Survival
|
81.1 months
Interval 68.0 to
Not enough event data to estimate the upper bound of the 95% CI for median OS for the TAK700 arm.
|
70.2 months
Interval 64.6 to 79.5
|
SECONDARY outcome
Timeframe: Duration of treatment and follow-up until death or 9 years after study startProgression Free Survival (PFS) is defined as the time from random assignment to first documentation of PSA progression, radiologic progression, clinical progression, or death, whichever occurred first. PSA progression is defined as a ≥25% increase AND and absolute increase of at last 2 ng/mL from the nadir PSA (or from baseline PSA if there was no drop in PSA after starting treatment). Radiologic progression is defined as two or more new lesions on radionuclide bone scans. Clinical progression is defined using the Response Evaluation Criteria in Solid Tumors (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
LHRHa + TAK-700
n=638 Participants
Experimental: ADT + TAK-700 LHRH agonist - given as approved for androgen deprivation at a dose necessary to maintain castrate levels and equivalent to 22.5 mg of Leuprolide IM every 3 months.
TAK-700, 300 mg, PO, twice daily
|
LHRHa + Bicalutamide
n=641 Participants
Active Comparator: ADT + Bicalutamide LHRH agonist - given as approved for androgen deprivation at a dose necessary to maintain castrate levels and equivalent to 22.5 mg of Leuprolide IM every 3 months.
Bicalutamide, 50 mg, PO, q daily
|
|---|---|---|
|
Progression Free Survival
|
47.6 months
Interval 42.2 to 54.2
|
23.0 months
Interval 19.3 to 26.3
|
SECONDARY outcome
Timeframe: 7 months after randomizationProstate-specific antigen (PSA) response rates were divided into complete response (CR: PSA \< 0.2 ng/mL), partial response (PR: PSA between 0.2 and 4.0 ng/mL), and no response (NR: PSA \> 4.0 ng/mL) at a 7-month landmark after random assignment.
Outcome measures
| Measure |
LHRHa + TAK-700
n=638 Participants
Experimental: ADT + TAK-700 LHRH agonist - given as approved for androgen deprivation at a dose necessary to maintain castrate levels and equivalent to 22.5 mg of Leuprolide IM every 3 months.
TAK-700, 300 mg, PO, twice daily
|
LHRHa + Bicalutamide
n=641 Participants
Active Comparator: ADT + Bicalutamide LHRH agonist - given as approved for androgen deprivation at a dose necessary to maintain castrate levels and equivalent to 22.5 mg of Leuprolide IM every 3 months.
Bicalutamide, 50 mg, PO, q daily
|
|---|---|---|
|
PSA Response Rates
Complete Response
|
58 percentage of participants
|
44 percentage of participants
|
|
PSA Response Rates
Partial Response
|
22 percentage of participants
|
31 percentage of participants
|
|
PSA Response Rates
No Response
|
19 percentage of participants
|
25 percentage of participants
|
SECONDARY outcome
Timeframe: Duration of treatment and follow-up until death or 9 years after study startPopulation: Eligible participants who received at least one dose of protocol treatment
Only adverse events that are possibly, probably or definitely related to study drug are reported. Adverse events are graded using the Common Terminology Criteria for Adverse Events (CTCAE v4.0) where grade refers to the severity of the AE. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE.
Outcome measures
| Measure |
LHRHa + TAK-700
n=627 Participants
Experimental: ADT + TAK-700 LHRH agonist - given as approved for androgen deprivation at a dose necessary to maintain castrate levels and equivalent to 22.5 mg of Leuprolide IM every 3 months.
TAK-700, 300 mg, PO, twice daily
|
LHRHa + Bicalutamide
n=629 Participants
Active Comparator: ADT + Bicalutamide LHRH agonist - given as approved for androgen deprivation at a dose necessary to maintain castrate levels and equivalent to 22.5 mg of Leuprolide IM every 3 months.
Bicalutamide, 50 mg, PO, q daily
|
|---|---|---|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Abdominal pain
|
4 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Acute coronary syndrome
|
1 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Acute kidney injury
|
0 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Adrenal insufficiency
|
2 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Adult respiratory distress syndrome
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Agitation
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Alanine aminotransferase increased
|
10 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Alkaline phosphatase increased
|
9 Participants
|
3 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Allergic reaction
|
2 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Anaphylaxis
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Anemia
|
1 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Anorexia
|
4 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hyperglycemia
|
11 Participants
|
6 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hyperkalemia
|
2 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypertension
|
127 Participants
|
28 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypertriglyceridemia
|
1 Participants
|
3 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hyperuricemia
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypokalemia
|
20 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hyponatremia
|
5 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypophosphatemia
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypotension
|
2 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypoxia
|
2 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Infections and infestations - Other, specify
|
2 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Insomnia
|
2 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Investigations - Other, specify
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Joint infection
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Laryngeal edema
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Left ventricular systolic dysfunction
|
2 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Leukocytosis
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Lipase increased
|
9 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Lung infection
|
5 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Lymphocyte count decreased
|
3 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Mucositis oral
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Multi-organ failure
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Muscle weakness lower limb
|
0 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Musculoskeletal and connective tiss disorder - Other
|
3 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Myalgia
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Myocardial infarction
|
5 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Nausea
|
5 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Neutrophil count decreased
|
1 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Obesity
|
0 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Osteoporosis
|
1 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Otitis media
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain
|
3 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pancreatitis
|
7 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Peripheral sensory neuropathy
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Platelet count decreased
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pneumonitis
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pruritus
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pulmonary edema
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pulmonary hypertension
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Renal calculi
|
0 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Resp, thoracic and mediastinal disorders - Other
|
2 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Serum amylase increased
|
2 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Skin and subcutaneous tissue disorders - Other
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Spinal fracture
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Stroke
|
2 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Supraventricular tachycardia
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Syncope
|
4 Participants
|
3 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Thromboembolic event
|
6 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Thrombotic thrombocytopenic purpura
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Urinary tract infection
|
4 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Urostomy stenosis
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Ventricular fibrillation
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Ventricular tachycardia
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Vomiting
|
4 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Weight gain
|
3 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Weight loss
|
4 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Anxiety
|
1 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Arthralgia
|
5 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Arthritis
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Aspartate aminotransferase increased
|
7 Participants
|
3 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Atrial fibrillation
|
8 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Back pain
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Blood bilirubin increased
|
4 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Bone pain
|
0 Participants
|
3 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Cardiac arrest
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Cardiac disorders - Other, specify
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Cardiac troponin I increased
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Chest pain - cardiac
|
4 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Colitis
|
2 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Concentration impairment
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Confusion
|
1 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Constipation
|
2 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Creatinine increased
|
1 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Death NOS
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dehydration
|
2 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Depression
|
7 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Diarrhea
|
10 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dizziness
|
3 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dysphagia
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dyspnea
|
9 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Edema limbs
|
4 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Ejection fraction decreased
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Encephalopathy
|
1 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Erectile dysfunction
|
4 Participants
|
4 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Esophagitis
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Fall
|
2 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Fatigue
|
34 Participants
|
11 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Fever
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Flank pain
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Flu like symptoms
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
GGT increased
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Gastric hemorrhage
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Gastric ulcer
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
General disorders and admin site conditions - Other
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Generalized muscle weakness
|
4 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Gynecomastia
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Headache
|
3 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Heart failure
|
6 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hematuria
|
1 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hepatobiliary disorders - Other, specify
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hip fracture
|
3 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hoarseness
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hot flashes
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: After 10 years of follow-upLong-term survival is defined as the time from random assignment to the date of death from any cause
Outcome measures
Outcome data not reported
Adverse Events
LHRHa + TAK-700
Serious events: 235 serious events
Other events: 615 other events
Deaths: 251 deaths
LHRHa + Bicalutamide
Serious events: 15 serious events
Other events: 609 other events
Deaths: 274 deaths
Serious adverse events
| Measure |
LHRHa + TAK-700
n=627 participants at risk
Experimental: ADT + TAK-700 LHRH agonist - given as approved for androgen deprivation at a dose necessary to maintain castrate levels and equivalent to 22.5 mg of Leuprolide IM every 3 months.
TAK-700, 300 mg, PO, twice daily
|
LHRHa + Bicalutamide
n=629 participants at risk
Active Comparator: ADT + Bicalutamide LHRH agonist - given as approved for androgen deprivation at a dose necessary to maintain castrate levels and equivalent to 22.5 mg of Leuprolide IM every 3 months.
Bicalutamide, 50 mg, PO, q daily
|
|---|---|---|
|
Infections and infestations
Upper respiratory infection
|
0.32%
2/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Infections and infestations
Urinary tract infection
|
2.2%
14/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Infections and infestations
Wound infection
|
0.80%
5/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Injury, poisoning and procedural complications
Aortic injury
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Injury, poisoning and procedural complications
Fall
|
1.4%
9/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.80%
5/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.1%
7/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Injury, poisoning and procedural complications
Injury, poison and procedural complications - Other
|
0.32%
2/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Investigations
Alanine aminotransferase increased
|
1.1%
7/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Investigations
Alkaline phosphatase increased
|
0.80%
5/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Investigations
Aspartate aminotransferase increased
|
0.80%
5/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Investigations
Blood bilirubin increased
|
0.96%
6/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Investigations
Cardiac troponin I increased
|
0.32%
2/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Investigations
Creatinine increased
|
0.32%
2/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Investigations
Ejection fraction decreased
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.32%
2/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Investigations
Investigations-Other
|
0.32%
2/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Investigations
Lipase increased
|
1.8%
11/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Investigations
Lymphocyte count decreased
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Investigations
Platelet count decreased
|
0.32%
2/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Investigations
Serum amylase increased
|
0.64%
4/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Investigations
Weight loss
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.3%
8/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.64%
4/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.32%
2/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.9%
12/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.80%
5/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.8%
11/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.16%
1/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.32%
2/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
1.1%
7/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.80%
5/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tiss disorder - Other
|
0.48%
3/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.32%
2/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.32%
2/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified - Other
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.48%
3/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Nervous system disorders
Ataxia
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.48%
3/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Nervous system disorders
Dizziness
|
1.3%
8/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Nervous system disorders
Encephalopathy
|
0.64%
4/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.16%
1/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Nervous system disorders
Headache
|
0.64%
4/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.48%
3/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Nervous system disorders
Lethargy
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Nervous system disorders
Memory impairment
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Nervous system disorders
Paresthesia
|
0.32%
2/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.32%
2/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Nervous system disorders
Presyncope
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Nervous system disorders
Seizure
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Nervous system disorders
Stroke
|
1.6%
10/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.16%
1/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Nervous system disorders
Syncope
|
2.1%
13/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Nervous system disorders
Transient ischemic attacks
|
0.32%
2/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Nervous system disorders
Vasovagal reaction
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.16%
1/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Psychiatric disorders
Anxiety
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Psychiatric disorders
Confusion
|
0.64%
4/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.16%
1/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Psychiatric disorders
Delirium
|
0.48%
3/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Psychiatric disorders
Depression
|
0.64%
4/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Psychiatric disorders
Hallucinations
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Psychiatric disorders
Insomnia
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Psychiatric disorders
Suicidal ideation
|
0.32%
2/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Psychiatric disorders
Suicide attempt
|
0.32%
2/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.4%
9/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.32%
2/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Renal and urinary disorders
Hematuria
|
1.3%
8/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Renal and urinary disorders
Renal and urinary disorders-Other
|
0.48%
3/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Renal and urinary disorders
Renal calculi
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Renal and urinary disorders
Urinary retention
|
0.64%
4/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.00%
0/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.16%
1/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.16%
1/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.48%
3/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.7%
23/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.8%
11/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.80%
5/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.48%
3/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic and mediastinal disorders - Other
|
0.32%
2/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.32%
2/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.16%
1/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Surgical and medical procedures
Surgical and medical procedures-Other
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Vascular disorders
Hematoma
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Vascular disorders
Hypertension
|
7.0%
44/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Vascular disorders
Hypotension
|
1.1%
7/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Vascular disorders
Thromboembolic event
|
3.2%
20/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Vascular disorders
Vascular disorders-Other
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Blood and lymphatic system disorders
Anemia
|
0.96%
6/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.48%
3/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Cardiac disorders
Aortic valve disease
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Cardiac disorders
Atrial fibrillation
|
2.9%
18/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Cardiac disorders
Cardiac arrest
|
0.96%
6/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.32%
2/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Cardiac disorders
Cardiac disorders-Other
|
0.80%
5/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Cardiac disorders
Chest pain - cardiac
|
2.6%
16/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Cardiac disorders
Heart failure
|
1.9%
12/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.32%
2/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Cardiac disorders
Mitral valve disease
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Cardiac disorders
Myocardial infarction
|
1.6%
10/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Cardiac disorders
Paroxysmal atrial tachycardia
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Cardiac disorders
Right ventricular dysfunction
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Cardiac disorders
Sinus bradycardia
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.32%
2/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Endocrine disorders
Hypothyroidism
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Eye disorders
Blurred vision
|
0.48%
3/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Eye disorders
Retinal detachment
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.6%
16/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Gastrointestinal disorders
Colitis
|
0.64%
4/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Gastrointestinal disorders
Colonic hemorrhage
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Gastrointestinal disorders
Constipation
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.16%
1/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Gastrointestinal disorders
Diarrhea
|
1.6%
10/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Gastrointestinal disorders
Dysphagia
|
0.32%
2/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Gastrointestinal disorders
Esophagitis
|
0.32%
2/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
0.32%
2/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Gastrointestinal disorders
Gastrointestinal disorders-Other
|
0.64%
4/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Gastrointestinal disorders
Ileal obstruction
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Gastrointestinal disorders
Nausea
|
1.6%
10/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Gastrointestinal disorders
Pancreatitis
|
1.3%
8/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.48%
3/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Gastrointestinal disorders
Vomiting
|
1.6%
10/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
General disorders
Chills
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
General disorders
Death NOS
|
0.80%
5/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.32%
2/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
General disorders
Edema face
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
General disorders
Edema limbs
|
0.64%
4/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
General disorders
Fatigue
|
1.6%
10/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
General disorders
Fever
|
1.6%
10/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
General disorders
Flu like symptoms
|
0.48%
3/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
General disorders
Gait disturbance
|
0.32%
2/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
General disorders
General disorders and admin site conditions - Other
|
0.32%
2/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
General disorders
Malaise
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
General disorders
Multi-organ failure
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.16%
1/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
General disorders
Non-cardiac chest pain
|
0.96%
6/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
General disorders
Pain
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
General disorders
Sudden death NOS
|
0.80%
5/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.16%
1/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Hepatobiliary disorders
Gallbladder obstruction
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Immune system disorders
Allergic reaction
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Immune system disorders
Anaphylaxis
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Infections and infestations
Abdominal infection
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Infections and infestations
Anorectal infection
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Infections and infestations
Appendicitis
|
0.32%
2/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Infections and infestations
Appendicitis perforated
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Infections and infestations
Bone infection
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Infections and infestations
Enterocolitis infectious
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Infections and infestations
Infections and infestations-Other
|
1.6%
10/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.16%
1/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Infections and infestations
Lung infection
|
3.8%
24/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Infections and infestations
Otitis media
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Infections and infestations
Prostate infection
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Infections and infestations
Sepsis
|
1.1%
7/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Infections and infestations
Skin infection
|
0.64%
4/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Infections and infestations
Soft tissue infection
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Infections and infestations
Tooth infection
|
0.16%
1/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
0.00%
0/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
Other adverse events
| Measure |
LHRHa + TAK-700
n=627 participants at risk
Experimental: ADT + TAK-700 LHRH agonist - given as approved for androgen deprivation at a dose necessary to maintain castrate levels and equivalent to 22.5 mg of Leuprolide IM every 3 months.
TAK-700, 300 mg, PO, twice daily
|
LHRHa + Bicalutamide
n=629 participants at risk
Active Comparator: ADT + Bicalutamide LHRH agonist - given as approved for androgen deprivation at a dose necessary to maintain castrate levels and equivalent to 22.5 mg of Leuprolide IM every 3 months.
Bicalutamide, 50 mg, PO, q daily
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
54.2%
340/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
43.1%
271/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Cardiac disorders
Sinus tachycardia
|
5.7%
36/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
2.4%
15/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Gastrointestinal disorders
Abdominal pain
|
14.0%
88/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
7.9%
50/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Gastrointestinal disorders
Constipation
|
36.4%
228/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
21.1%
133/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Gastrointestinal disorders
Diarrhea
|
28.9%
181/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
14.3%
90/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Gastrointestinal disorders
Dry mouth
|
7.3%
46/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
2.5%
16/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.7%
36/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
2.2%
14/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Gastrointestinal disorders
Flatulence
|
6.5%
41/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
3.2%
20/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Gastrointestinal disorders
Gastrointestinal disorders-Other
|
6.1%
38/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
2.7%
17/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Gastrointestinal disorders
Nausea
|
34.1%
214/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
13.7%
86/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Gastrointestinal disorders
Vomiting
|
19.1%
120/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
7.5%
47/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
General disorders
Chills
|
5.3%
33/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
3.0%
19/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
General disorders
Edema limbs
|
23.9%
150/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
17.5%
110/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
General disorders
Fatigue
|
71.0%
445/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
55.0%
346/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
General disorders
Flu like symptoms
|
6.5%
41/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
5.4%
34/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
General disorders
General disorders and admin site conditions - Other
|
9.7%
61/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
7.5%
47/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
General disorders
Non-cardiac chest pain
|
7.5%
47/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
4.0%
25/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
General disorders
Pain
|
33.2%
208/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
24.8%
156/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Infections and infestations
Infections and infestations-Other
|
9.1%
57/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
4.1%
26/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Infections and infestations
Upper respiratory infection
|
7.2%
45/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
4.6%
29/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Infections and infestations
Urinary tract infection
|
7.7%
48/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
4.1%
26/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Injury, poisoning and procedural complications
Fall
|
9.9%
62/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
5.4%
34/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Investigations
Alanine aminotransferase increased
|
28.5%
179/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
13.5%
85/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Investigations
Alkaline phosphatase increased
|
21.5%
135/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
17.0%
107/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Investigations
Aspartate aminotransferase increased
|
29.0%
182/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
13.7%
86/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Investigations
Blood bilirubin increased
|
6.4%
40/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
5.7%
36/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Investigations
Cholesterol high
|
8.1%
51/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
8.3%
52/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Investigations
Creatinine increased
|
24.1%
151/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
15.7%
99/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Investigations
Investigations-Other
|
7.8%
49/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
3.3%
21/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Investigations
Lymphocyte count decreased
|
20.4%
128/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
8.3%
52/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Investigations
Neutrophil count decreased
|
6.1%
38/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
5.1%
32/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Investigations
Platelet count decreased
|
15.2%
95/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
9.5%
60/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Investigations
Weight gain
|
10.5%
66/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
16.4%
103/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Investigations
Weight loss
|
20.7%
130/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
6.0%
38/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Investigations
White blood cell decreased
|
14.4%
90/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
8.7%
55/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Metabolism and nutrition disorders
Anorexia
|
21.4%
134/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
9.5%
60/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
8.5%
53/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
8.6%
54/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
38.9%
244/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
27.3%
172/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
11.6%
73/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
5.7%
36/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
9.9%
62/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
4.8%
30/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
13.6%
85/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
9.2%
58/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
9.3%
58/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
4.0%
25/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
10.0%
63/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
5.1%
32/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
20.7%
130/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
5.9%
37/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
13.9%
87/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
9.4%
59/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
157/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
16.1%
101/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
8.5%
53/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
3.5%
22/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
34.0%
213/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
30.8%
194/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
10.5%
66/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
11.8%
74/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
16.4%
103/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
8.7%
55/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tiss disorder - Other
|
13.6%
85/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
9.9%
62/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.1%
101/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
10.0%
63/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.5%
47/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
5.7%
36/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
8.1%
51/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
4.5%
28/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
35.1%
220/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
23.4%
147/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified - Other
|
5.1%
32/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
3.0%
19/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Nervous system disorders
Dizziness
|
24.2%
152/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
15.7%
99/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Nervous system disorders
Dysgeusia
|
8.1%
51/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
2.5%
16/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Nervous system disorders
Headache
|
30.3%
190/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
13.4%
84/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Nervous system disorders
Memory impairment
|
6.9%
43/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
4.3%
27/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
16.4%
103/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
11.1%
70/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Psychiatric disorders
Anxiety
|
14.4%
90/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
8.1%
51/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Psychiatric disorders
Depression
|
18.8%
118/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
12.7%
80/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Psychiatric disorders
Insomnia
|
27.0%
169/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
15.3%
96/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Psychiatric disorders
Libido decreased
|
5.3%
33/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
6.4%
40/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Renal and urinary disorders
Hematuria
|
9.3%
58/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
6.0%
38/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Renal and urinary disorders
Renal and urinary disorders-Other
|
9.3%
58/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
5.9%
37/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Renal and urinary disorders
Urinary frequency
|
24.7%
155/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
18.1%
114/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Renal and urinary disorders
Urinary incontinence
|
11.0%
69/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
8.4%
53/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Renal and urinary disorders
Urinary retention
|
6.4%
40/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
3.5%
22/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
9.9%
62/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
11.1%
70/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Reproductive system and breast disorders
Gynecomastia
|
6.9%
43/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
11.4%
72/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
5.3%
33/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
1.3%
8/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
24.2%
152/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
13.5%
85/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
23.4%
147/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
14.3%
90/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.1%
51/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
4.6%
29/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.6%
35/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
4.9%
31/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.8%
55/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
4.3%
27/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.8%
55/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
3.0%
19/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
12.3%
77/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
6.0%
38/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
10.8%
68/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
7.0%
44/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Vascular disorders
Hot flashes
|
71.5%
448/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
72.0%
453/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Vascular disorders
Hypertension
|
58.1%
364/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
35.3%
222/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
|
Vascular disorders
Hypotension
|
5.6%
35/627 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
1.9%
12/629 • Duration of treatment and follow-up until death or 9 years after study start
1,256 eligible participants who received protocol treatment were evaluable for AEs: 627 on the LHRHa + TAK-700 arm and 629 on the LHRHa + Bicalutamide arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0. All 1,279 participants who started the study, 638 on the LHRHa + TAK-700 arm and 641 on the LHRHa + Bicalutamide arm, were evaluated for All-Cause Mortality.
|
Additional Information
Genitourinary Committee Statistician
SWOG Statistics and Data Management Center
Phone: 2066674623
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60