Trial Outcomes & Findings for Prostate Cancer Prevention Study for Men With High Grade PIN (Prostatic Intraepithelial Neoplasia) (NCT NCT00106691)
NCT ID: NCT00106691
Last Updated: 2023-06-12
Results Overview
To measure the efficacy of toremifene citrate in men with high grade prostatic intraepithelial neoplasia (PIN). Prostate cancer-free survival distributions (Kaplan-Meier)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1589 participants
Primary outcome timeframe
The outcome measurement time is up to 36 months
Results posted on
2023-06-12
Participant Flow
1,589 subjects were recruited
Participant milestones
| Measure |
Placebo
matching placebo
|
Toremifene 20mg
toremifene 20mg group tablet q.d.
|
|---|---|---|
|
Overall Study
STARTED
|
802
|
787
|
|
Overall Study
COMPLETED
|
598
|
588
|
|
Overall Study
NOT COMPLETED
|
204
|
199
|
Reasons for withdrawal
| Measure |
Placebo
matching placebo
|
Toremifene 20mg
toremifene 20mg group tablet q.d.
|
|---|---|---|
|
Overall Study
Adverse Event
|
60
|
64
|
|
Overall Study
Lost to Follow-up
|
23
|
18
|
|
Overall Study
Physician Decision
|
18
|
21
|
|
Overall Study
Protocol Violation
|
13
|
18
|
|
Overall Study
Withdrawal by Subject
|
75
|
70
|
|
Overall Study
Failure to comply w/dosing regimen
|
6
|
4
|
|
Overall Study
QTc>480
|
3
|
1
|
|
Overall Study
mililtary deployment
|
2
|
0
|
|
Overall Study
Study Site Closing/PI Moved
|
1
|
2
|
|
Overall Study
Cardiologist recommendation
|
1
|
0
|
|
Overall Study
Pt. moved to another state
|
1
|
0
|
|
Overall Study
Taking exclusionary avodart
|
1
|
0
|
|
Overall Study
Not able to discontinue plavix
|
0
|
1
|
Baseline Characteristics
Prostate Cancer Prevention Study for Men With High Grade PIN (Prostatic Intraepithelial Neoplasia)
Baseline characteristics by cohort
| Measure |
Toremifene 20mg
n=787 Participants
toremifene 20mg arm
|
Placebo
n=802 Participants
Placebo group
|
Total
n=1589 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
425 Participants
n=5 Participants
|
434 Participants
n=7 Participants
|
859 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
362 Participants
n=5 Participants
|
368 Participants
n=7 Participants
|
730 Participants
n=5 Participants
|
|
Age, Continuous
|
64.4 years
STANDARD_DEVIATION 7.45 • n=5 Participants
|
64.4 years
STANDARD_DEVIATION 7.96 • n=7 Participants
|
64.4 years
STANDARD_DEVIATION 7.70 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
787 Participants
n=5 Participants
|
802 Participants
n=7 Participants
|
1589 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
682 participants
n=5 Participants
|
688 participants
n=7 Participants
|
1370 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
97 participants
n=5 Participants
|
104 participants
n=7 Participants
|
201 participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
8 participants
n=5 Participants
|
10 participants
n=7 Participants
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: The outcome measurement time is up to 36 monthsPopulation: MITT: Randomized subjects who were given study drug and did not return it unused and had a baseline and on-study prostate biopsy
To measure the efficacy of toremifene citrate in men with high grade prostatic intraepithelial neoplasia (PIN). Prostate cancer-free survival distributions (Kaplan-Meier)
Outcome measures
| Measure |
Placebo
n=717 Participants
Placebo group
|
Toremifene 20mg
n=709 Participants
Toremifene 20mg group
|
|---|---|---|
|
Efficacy of Toremifene in the Prevention of Prostate Cancer in Men With High Grade Prostatic Intraepithelial Neoplasia (PIN)
|
54.9 % of participants cancer-free 36 months
95% Confidence Interval 36.0 • Interval 43.3 to 66.5
|
59.5 % of participants cancer-free 36 months
95% Confidence Interval 36.0 • Interval 48.1 to 70.9
|
PRIMARY outcome
Timeframe: Up to 36 monthsPopulation: Modified, intend-to-treat (MITT) all randomized subj. who take at least 1 dose of study drug, and had baseline and on-study prostate biopsies, where the baseline biopsy did not have cancer.
To measure the occurrence of a positive cancer biopsy
Outcome measures
| Measure |
Placebo
n=717 Participants
Placebo group
|
Toremifene 20mg
n=709 Participants
Toremifene 20mg group
|
|---|---|---|
|
Occurrence of a Positive Cancer Biopsy
|
23.5 Months
Interval 8.8 to 32.0
|
15.9 Months
Interval 11.1 to 33.0
|
SECONDARY outcome
Timeframe: Up to 36 monthsPopulation: All randomized subjects who take at least 1 dose of study drug
Measure lipid levels including total cholesterol, LDL, HDL and Triglycerides % change from baseline
Outcome measures
| Measure |
Placebo
n=802 Participants
Placebo group
|
Toremifene 20mg
n=787 Participants
Toremifene 20mg group
|
|---|---|---|
|
The Effect of Toremifene on Lipid Levels
Cholesterol
|
-3.678 % of change
Standard Deviation 18.2317
|
-6.675 % of change
Standard Deviation 116.9705
|
|
The Effect of Toremifene on Lipid Levels
LDL
|
-7.447 % of change
Standard Deviation 64.8765
|
-7.824 % of change
Standard Deviation 28.8209
|
|
The Effect of Toremifene on Lipid Levels
HDL
|
3.69 % of change
Standard Deviation 19.133
|
0.29 % of change
Standard Deviation 16.650
|
|
The Effect of Toremifene on Lipid Levels
Triglycerides
|
16.298 % of change
Standard Deviation 58.003
|
0.319 % of change
Standard Deviation 47.9793
|
SECONDARY outcome
Timeframe: Up to 36 monthsPopulation: Any randomized subject taking at least 1 dose of study drug
% Change from baseline hormone levels, including total testosterone, free testosterone, dihydrotestosterone (DHT) and estradiol
Outcome measures
| Measure |
Placebo
n=802 Participants
Placebo group
|
Toremifene 20mg
n=787 Participants
Toremifene 20mg group
|
|---|---|---|
|
The Effect of Toremifene on Hormone Levels
DHT
|
17.736 % of change
Standard Deviation 48.3284
|
46.409 % of change
Standard Deviation 60.2061
|
|
The Effect of Toremifene on Hormone Levels
Estradiol
|
11.9 % of change
Standard Deviation 67.86
|
53.2 % of change
Standard Deviation 151.5
|
|
The Effect of Toremifene on Hormone Levels
Testosterone total
|
2.246 % of change
Standard Deviation 102.9086
|
31.136 % of change
Standard Deviation 63.5961
|
|
The Effect of Toremifene on Hormone Levels
Testosterone free
|
17.71 % of change
Standard Deviation 438.652
|
7.92 % of change
Standard Deviation 65.114
|
SECONDARY outcome
Timeframe: Up to 36 monthsPopulation: Any randomized subject taking at least 1 dose of study drug
To assess the effect of toremifene in the total PSA (prostate specific antigen) levels from baseline
Outcome measures
| Measure |
Placebo
n=790 Participants
Placebo group
|
Toremifene 20mg
n=776 Participants
Toremifene 20mg group
|
|---|---|---|
|
The Effect of Toremifene on Total PSA (Prostate Specific Antigen) Levels
|
0.82 mcg/L
Standard Deviation 7.360
|
1.07 mcg/L
Standard Deviation 3.632
|
SECONDARY outcome
Timeframe: 36 monthsPopulation: Reference to J Urol.1992 Nov;148(5):1549-57; discussion 1564. AUA symptom index for benign prostatic hyperplasia. The Measurement Committee of the American Urological Assocciation.
To assess the effect of toremifene on the AUA (American Urological Association) symptom score mean change from baseline. Scores of 0-7=mild severity, 8-9, moderate, and 20-30, severe with possible responses of 0 (not at all) 1 (\<1/5), 2 (\<50% time), 3 (about 50% time), 4 (\> 50% time) \& 5 (Almost Always). There are 7 questions (1)Incomplete emptying (2)Frequency (3)Intermittency (4)Urgency (5)Weak-stream (6)Straining \& (7)Nocturia. Analysis is change from baseline at final evaluation (36 months) for quality of life due to urinary symptoms. The P Value is from a Wilcoxon signed-rank test. Scores can range from 0-35, highest representing worse symptoms
Outcome measures
| Measure |
Placebo
n=676 Participants
Placebo group
|
Toremifene 20mg
n=653 Participants
Toremifene 20mg group
|
|---|---|---|
|
The Effect of Toremifene on the Mean Change at 36 Months in AUA (American Urological Association) Symptom Score
|
1.1 scores on a scale
Standard Deviation 5.4
|
1.2 scores on a scale
Standard Deviation 5.6
|
SECONDARY outcome
Timeframe: Up to 36 monthsPopulation: All randomized subjects that took 1 dose of study drug
To measure the occurrence of high grade PIN at the 12, 24, 36 Month intervals in the 360 days study.
Outcome measures
| Measure |
Placebo
n=802 Participants
Placebo group
|
Toremifene 20mg
n=787 Participants
Toremifene 20mg group
|
|---|---|---|
|
Occurrence of High Grade PIN at the 12, 24, 36 Month Biopsies
12 months
|
167 Subjects
|
149 Subjects
|
|
Occurrence of High Grade PIN at the 12, 24, 36 Month Biopsies
24 months
|
90 Subjects
|
103 Subjects
|
|
Occurrence of High Grade PIN at the 12, 24, 36 Month Biopsies
36 months
|
92 Subjects
|
94 Subjects
|
SECONDARY outcome
Timeframe: 36 monthsPopulation: Any randomized subject taking at least 1 dose of study drug
To assess the effect of toremifene in % free serum PSA (prostate specific antigen) levels, change from baseline
Outcome measures
| Measure |
Placebo
n=358 Participants
Placebo group
|
Toremifene 20mg
n=356 Participants
Toremifene 20mg group
|
|---|---|---|
|
The Effect of Toremifene on % Free Serum PSA (Prostate Specific Antigen) Levels, Change From Baseline
|
2.3 mcg/L
Standard Deviation 11.24
|
2.0 mcg/L
Standard Deviation 10.49
|
Adverse Events
Placebo
Serious events: 137 serious events
Other events: 666 other events
Deaths: 0 deaths
Toremifene 20mg
Serious events: 117 serious events
Other events: 631 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=802 participants at risk
Placebo Group
|
Toremifene 20mg
n=787 participants at risk
Toremifene 20mg group
|
|---|---|---|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.00%
0/802 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Cardiac disorders
Acute myocardial infarction
|
0.25%
2/802 • Number of events 2 • Three years
|
0.00%
0/787 • Three years
|
|
Endocrine disorders
Angina Pectoris
|
0.12%
1/802 • Number of events 1 • Three years
|
0.25%
2/787 • Number of events 2 • Three years
|
|
Cardiac disorders
Angina unstable
|
0.12%
1/802 • Number of events 1 • Three years
|
0.25%
2/787 • Number of events 2 • Three years
|
|
Cardiac disorders
Aortic Valve disease
|
0.12%
1/802 • Number of events 1 • Three years
|
0.00%
0/787 • Three years
|
|
Cardiac disorders
Atrial Fibrillation
|
0.50%
4/802 • Number of events 4 • Three years
|
0.64%
5/787 • Number of events 5 • Three years
|
|
Cardiac disorders
Atrial Flutter
|
0.25%
2/802 • Number of events 2 • Three years
|
0.38%
3/787 • Number of events 3 • Three years
|
|
Cardiac disorders
Cardiac Disorder
|
0.12%
1/802 • Number of events 1 • Three years
|
0.00%
0/787 • Three years
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.25%
2/802 • Number of events 3 • Three years
|
0.25%
2/787 • Number of events 3 • Three years
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.12%
1/802 • Number of events 1 • Three years
|
0.00%
0/787 • Three years
|
|
Cardiac disorders
Coronary artery disease
|
1.9%
15/802 • Number of events 16 • Three years
|
0.89%
7/787 • Number of events 7 • Three years
|
|
Cardiac disorders
Hypertrophic obstructive cardiomyopathy
|
0.12%
1/802 • Number of events 1 • Three years
|
0.00%
0/787 • Three years
|
|
Cardiac disorders
Mitral valve incompetence
|
0.12%
1/802 • Number of events 1 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Cardiac disorders
Myocardial infarction
|
0.75%
6/802 • Number of events 6 • Three years
|
0.25%
2/787 • Number of events 2 • Three years
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/802 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Cardiac disorders
Ventricular tachycardia
|
0.25%
2/802 • Number of events 2 • Three years
|
0.00%
0/787 • Three years
|
|
Blood and lymphatic system disorders
Idiopathic Thrombocytopenic purpura
|
0.00%
0/802 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Congenital, familial and genetic disorders
Spondylolisthesis
|
0.00%
0/802 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/802 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.12%
1/802 • Number of events 1 • Three years
|
0.00%
0/787 • Three years
|
|
Gastrointestinal disorders
Abdominal strangulated hernia
|
0.00%
0/802 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Gastrointestinal disorders
Appendicitis perforated
|
0.12%
1/802 • Number of events 1 • Three years
|
0.00%
0/787 • Three years
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/802 • Three years
|
0.25%
2/787 • Number of events 2 • Three years
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.12%
1/802 • Number of events 1 • Three years
|
0.00%
0/787 • Three years
|
|
Gastrointestinal disorders
Colonic haematoma
|
0.12%
1/802 • Number of events 1 • Three years
|
0.00%
0/787 • Three years
|
|
Gastrointestinal disorders
Colonic polyp
|
0.12%
1/802 • Number of events 1 • Three years
|
0.00%
0/787 • Three years
|
|
Gastrointestinal disorders
Diverticulitis intestinal haemorrhagic
|
0.00%
0/802 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.00%
0/802 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.12%
1/802 • Number of events 1 • Three years
|
0.00%
0/787 • Three years
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.12%
1/802 • Number of events 1 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.37%
3/802 • Number of events 3 • Three years
|
0.00%
0/787 • Three years
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.12%
1/802 • Number of events 1 • Three years
|
0.00%
0/787 • Three years
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.12%
1/802 • Number of events 1 • Three years
|
0.25%
2/787 • Number of events 2 • Three years
|
|
Gastrointestinal disorders
Intestinal infarction
|
0.00%
0/802 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.12%
1/802 • Number of events 1 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/802 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Gastrointestinal disorders
Oesophageal ulcer haemorrhage
|
0.12%
1/802 • Number of events 1 • Three years
|
0.00%
0/787 • Three years
|
|
Gastrointestinal disorders
Oesophagitis
|
0.12%
1/802 • Number of events 1 • Three years
|
0.00%
0/787 • Three years
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/802 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.12%
1/802 • Number of events 1 • Three years
|
0.25%
2/787 • Number of events 2 • Three years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/802 • Three years
|
0.25%
2/787 • Number of events 2 • Three years
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.12%
1/802 • Number of events 1 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
General disorders
Asthenia
|
0.00%
0/802 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
General disorders
Chest discomfort
|
0.12%
1/802 • Number of events 1 • Three years
|
0.00%
0/787 • Three years
|
|
General disorders
Chest pain
|
0.12%
1/802 • Number of events 1 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
General disorders
Non-cardiac chest pain
|
0.62%
5/802 • Number of events 5 • Three years
|
0.38%
3/787 • Number of events 3 • Three years
|
|
General disorders
Sudden death
|
0.12%
1/802 • Number of events 1 • Three years
|
0.00%
0/787 • Three years
|
|
Hepatobiliary disorders
Cholecystitis
|
0.12%
1/802 • Number of events 1 • Three years
|
0.25%
2/787 • Number of events 2 • Three years
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.25%
2/802 • Number of events 2 • Three years
|
0.00%
0/787 • Three years
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.25%
2/802 • Number of events 2 • Three years
|
0.00%
0/787 • Three years
|
|
Infections and infestations
Appendicitis
|
0.25%
2/802 • Number of events 2 • Three years
|
0.25%
2/787 • Number of events 2 • Three years
|
|
Infections and infestations
Bronchititis
|
0.12%
1/802 • Number of events 1 • Three years
|
0.00%
0/787 • Three years
|
|
Infections and infestations
Cellulitis
|
0.12%
1/802 • Number of events 1 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Infections and infestations
Central line infection
|
0.12%
1/802 • Number of events 1 • Three years
|
0.00%
0/787 • Three years
|
|
Infections and infestations
Cholecystitis infective
|
0.12%
1/802 • Number of events 1 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Infections and infestations
Clostridium colitis
|
0.12%
1/802 • Number of events 1 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Infections and infestations
Cytomegalovirus infection
|
0.12%
1/802 • Number of events 1 • Three years
|
0.00%
0/787 • Three years
|
|
Infections and infestations
Diverticulitis
|
0.12%
1/802 • Number of events 1 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Infections and infestations
Empyema
|
0.00%
0/802 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Infections and infestations
Escherichia bacteraemia
|
0.12%
1/802 • Number of events 1 • Three years
|
0.00%
0/787 • Three years
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/802 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Infections and infestations
Escherichia sepsis
|
0.12%
1/802 • Number of events 1 • Three years
|
0.00%
0/787 • Three years
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/802 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/802 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Infections and infestations
Human ehrlichiosis
|
0.00%
0/802 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Infections and infestations
Lyme disease
|
0.00%
0/802 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Infections and infestations
Pneumonia
|
0.62%
5/802 • Number of events 5 • Three years
|
0.76%
6/787 • Number of events 7 • Three years
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/802 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Infections and infestations
Pneumonia streptococcal
|
0.12%
1/802 • Number of events 1 • Three years
|
0.00%
0/787 • Three years
|
|
Infections and infestations
Postoperative abscess
|
0.12%
1/802 • Number of events 1 • Three years
|
0.00%
0/787 • Three years
|
|
Infections and infestations
Postoperative infection
|
0.25%
2/802 • Number of events 2 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Infections and infestations
Sepsis
|
0.37%
3/802 • Number of events 3 • Three years
|
0.51%
4/787 • Number of events 4 • Three years
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/802 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Infections and infestations
Streptococcal sepsis
|
0.00%
0/802 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Infections and infestations
Urinary tract infection
|
0.37%
3/802 • Number of events 3 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Infections and infestations
Urosepsis
|
0.50%
4/802 • Number of events 4 • Three years
|
0.76%
6/787 • Number of events 6 • Three years
|
|
Infections and infestations
Wound infection staphylococcal
|
0.12%
1/802 • Number of events 1 • Three years
|
0.00%
0/787 • Three years
|
|
Injury, poisoning and procedural complications
Device failure
|
0.00%
0/802 • Three years
|
0.25%
2/787 • Number of events 2 • Three years
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/802 • Three years
|
0.38%
3/787 • Number of events 3 • Three years
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.12%
1/802 • Number of events 1 • Three years
|
0.00%
0/787 • Three years
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.12%
1/802 • Number of events 1 • Three years
|
0.00%
0/787 • Three years
|
|
Injury, poisoning and procedural complications
Nerve root injury
|
0.12%
1/802 • Number of events 1 • Three years
|
0.00%
0/787 • Three years
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.50%
4/802 • Number of events 4 • Three years
|
0.00%
0/787 • Three years
|
|
Injury, poisoning and procedural complications
Postoperative fever
|
0.00%
0/802 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/802 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.12%
1/802 • Number of events 1 • Three years
|
0.25%
2/787 • Number of events 2 • Three years
|
|
Injury, poisoning and procedural complications
Surgical procedure repeated
|
0.12%
1/802 • Number of events 1 • Three years
|
0.00%
0/787 • Three years
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.12%
1/802 • Number of events 1 • Three years
|
0.00%
0/787 • Three years
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.12%
1/802 • Number of events 1 • Three years
|
0.00%
0/787 • Three years
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/802 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Metabolism and nutrition disorders
Diabetes mellitus insulin-dependent
|
0.00%
0/802 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/802 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/802 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/802 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/802 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.12%
1/802 • Number of events 1 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/802 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.12%
1/802 • Number of events 1 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.37%
3/802 • Number of events 3 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Musculoskeletal and connective tissue disorders
Localised osteoarthritis
|
0.62%
5/802 • Number of events 6 • Three years
|
0.64%
5/787 • Number of events 5 • Three years
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.37%
3/802 • Number of events 3 • Three years
|
0.38%
3/787 • Number of events 3 • Three years
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.1%
9/802 • Number of events 11 • Three years
|
0.76%
6/787 • Number of events 6 • Three years
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/802 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.12%
1/802 • Number of events 1 • Three years
|
0.00%
0/787 • Three years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder adenocarcinoma stage unspecified
|
0.00%
0/802 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/802 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell carcinoma of the kidney
|
0.00%
0/802 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage II
|
0.00%
0/802 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/802 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage unspecified
|
0.00%
0/802 • Three years
|
0.25%
2/787 • Number of events 2 • Three years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/802 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.12%
1/802 • Number of events 1 • Three years
|
0.00%
0/787 • Three years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenoma
|
0.12%
1/802 • Number of events 1 • Three years
|
0.00%
0/787 • Three years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/802 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma stage unspecified
|
0.00%
0/802 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Nervous system disorders
Amyotrophic lateral sclerosis
|
0.12%
1/802 • Number of events 1 • Three years
|
0.00%
0/787 • Three years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/802 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Nervous system disorders
Brain stem infarction
|
0.00%
0/802 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Nervous system disorders
Carotid artery occlusion
|
0.12%
1/802 • Number of events 1 • Three years
|
0.00%
0/787 • Three years
|
|
Nervous system disorders
Carotid artery stenosis
|
0.12%
1/802 • Number of events 1 • Three years
|
0.00%
0/787 • Three years
|
|
Nervous system disorders
Cerebrovascular accident
|
0.12%
1/802 • Number of events 1 • Three years
|
0.00%
0/787 • Three years
|
|
Nervous system disorders
Cervical myelopathy
|
0.25%
2/802 • Number of events 2 • Three years
|
0.00%
0/787 • Three years
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/802 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Nervous system disorders
Intracranial aneurysm
|
0.12%
1/802 • Number of events 1 • Three years
|
0.00%
0/787 • Three years
|
|
Nervous system disorders
Loss of consciousness
|
0.12%
1/802 • Number of events 1 • Three years
|
0.00%
0/787 • Three years
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/802 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Nervous system disorders
Status epilepticus
|
0.12%
1/802 • Number of events 1 • Three years
|
0.00%
0/787 • Three years
|
|
Nervous system disorders
Syncope
|
0.25%
2/802 • Number of events 2 • Three years
|
0.25%
2/787 • Number of events 2 • Three years
|
|
Nervous system disorders
Syncope vasovagal
|
0.12%
1/802 • Number of events 1 • Three years
|
0.00%
0/787 • Three years
|
|
Nervous system disorders
Transient ischaemic attack
|
0.12%
1/802 • Number of events 1 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Psychiatric disorders
Anxiety
|
0.12%
1/802 • Number of events 1 • Three years
|
0.00%
0/787 • Three years
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/802 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Psychiatric disorders
Depression
|
0.25%
2/802 • Number of events 2 • Three years
|
0.25%
2/787 • Number of events 2 • Three years
|
|
Psychiatric disorders
Major depression
|
0.00%
0/802 • Three years
|
0.13%
1/787 • Number of events 2 • Three years
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/802 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Renal and urinary disorders
Bladder diverticulum
|
0.00%
0/802 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Renal and urinary disorders
Bladder neck obstruction
|
0.12%
1/802 • Number of events 1 • Three years
|
0.00%
0/787 • Three years
|
|
Renal and urinary disorders
Calculus bladder
|
0.00%
0/802 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Renal and urinary disorders
Calculus ureteric
|
0.12%
1/802 • Number of events 1 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Renal and urinary disorders
Haematuria
|
0.12%
1/802 • Number of events 1 • Three years
|
0.13%
1/787 • Number of events 1 • Three years
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.12%
1/802 • Number of events 1 • Three years
|
0.38%
3/787 • Number of events 3 • Three years
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.12%
1/802 • Number of events 1 • Three years
|
0.00%
0/787 • Three years
|
|
Renal and urinary disorders
Renal colic
|
0.12%
1/802 • Number of events 1 • Three years
|
0.00%
0/787 • Three years
|
Other adverse events
| Measure |
Placebo
n=802 participants at risk
Placebo Group
|
Toremifene 20mg
n=787 participants at risk
Toremifene 20mg group
|
|---|---|---|
|
Vascular disorders
Hypertension
|
8.7%
70/802 • Number of events 70 • Three years
|
6.6%
52/787 • Number of events 52 • Three years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
50/802 • Number of events 61 • Three years
|
5.8%
46/787 • Number of events 50 • Three years
|
|
Infections and infestations
Urinary tract infection
|
6.7%
54/802 • Number of events 65 • Three years
|
5.2%
41/787 • Number of events 45 • Three years
|
|
Infections and infestations
Upper respiratory tract infection
|
5.7%
46/802 • Number of events 57 • Three years
|
5.7%
45/787 • Number of events 53 • Three years
|
|
Reproductive system and breast disorders
Prostatitis
|
6.1%
49/802 • Number of events 62 • Three years
|
5.0%
39/787 • Number of events 43 • Three years
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
5.2%
42/802 • Number of events 42 • Three years
|
5.3%
42/787 • Number of events 43 • Three years
|
|
Renal and urinary disorders
Haematuria
|
4.7%
38/802 • Number of events 49 • Three years
|
4.6%
36/787 • Number of events 43 • Three years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.5%
36/802 • Number of events 41 • Three years
|
3.9%
31/787 • Number of events 32 • Three years
|
|
Nervous system disorders
Dizziness
|
4.6%
37/802 • Number of events 42 • Three years
|
3.8%
30/787 • Number of events 32 • Three years
|
|
Infections and infestations
Nasopharyngitis
|
4.9%
39/802 • Number of events 42 • Three years
|
3.6%
28/787 • Number of events 30 • Three years
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
3.7%
30/802 • Number of events 31 • Three years
|
4.1%
32/787 • Number of events 32 • Three years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.6%
29/802 • Number of events 29 • Three years
|
4.1%
32/787 • Number of events 34 • Three years
|
|
General disorders
Fatigue
|
3.9%
31/802 • Number of events 32 • Three years
|
3.6%
28/787 • Number of events 28 • Three years
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
4.0%
32/802 • Number of events 34 • Three years
|
3.0%
24/787 • Number of events 24 • Three years
|
|
Renal and urinary disorders
Pollakiuria
|
3.7%
30/802 • Number of events 30 • Three years
|
3.3%
26/787 • Number of events 27 • Three years
|
|
Eye disorders
Cataract
|
3.0%
24/802 • Number of events 32 • Three years
|
3.7%
29/787 • Number of events 37 • Three years
|
|
Psychiatric disorders
Insomnia
|
4.0%
32/802 • Number of events 34 • Three years
|
2.7%
21/787 • Number of events 21 • Three years
|
|
Infections and infestations
Sinusitis
|
2.6%
21/802 • Number of events 23 • Three years
|
4.1%
32/787 • Number of events 34 • Three years
|
|
Renal and urinary disorders
Urinary retention
|
3.0%
24/802 • Number of events 28 • Three years
|
3.7%
29/787 • Number of events 34 • Three years
|
|
Gastrointestinal disorders
Constipation
|
3.4%
27/802 • Number of events 27 • Three years
|
3.0%
24/787 • Number of events 24 • Three years
|
|
Nervous system disorders
Headache
|
3.4%
27/802 • Number of events 29 • Three years
|
2.8%
22/787 • Number of events 27 • Three years
|
|
Renal and urinary disorders
Nocturia
|
2.9%
23/802 • Number of events 24 • Three years
|
3.2%
25/787 • Number of events 26 • Three years
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
3.2%
26/802 • Number of events 26 • Three years
|
2.7%
21/787 • Number of events 21 • Three years
|
|
Gastrointestinal disorders
Nausea
|
3.2%
26/802 • Number of events 29 • Three years
|
2.7%
21/787 • Number of events 22 • Three years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Disclosure restriction: PIs may publish/present trial results at med. conferences after 1st of 1 of following occurs: complete Multicenter Study publication presented/Sponsor confirms there won't be Multicenter Study publication/18 mos. elapsed after Study ends. PI:submits advance copy w/in 60 days. Sponsor:60 days to review. Sponsor:tells PI w/in 60 days the pres./pub. might have adverse effect to obtain patents on inventions or confidentiality of info, PI can't make pres/pub w/o changes
- Publication restrictions are in place
Restriction type: OTHER