Trial Outcomes & Findings for Adjuvant Leuprolide With or Without Docetaxel in High Risk Prostate Cancer After Radical Prostatectomy (NCT NCT00283062)
NCT ID: NCT00283062
Last Updated: 2012-01-26
Results Overview
PFS is the interval from the date of surgery to date of progression. The date of progression was the earlier of * first PSA increase to ≥ 0.4 ng/mL confirmed within two weeks * date of the nadir, if PSA nadir did not reach \< 0.4 ng/mL (for deferred arm) * first radiological/ histological evidence of tumor progression * death. Median PFS was to be estimated using Kaplan-Meier curves. However, enrollment was not met, and meaningful conclusions for efficacy or QoL could not be drawn. Median PFS could not be estimated. Reported is the number of participants with disease progression.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
228 participants
Primary outcome timeframe
from the date of surgery up to 3 years after randomization of the last participant
Results posted on
2012-01-26
Participant Flow
Originally, the study was planned for 1696 participants to be randomized. However, enrollment was not met and in September 2007, the Steering Committee decided to stop recruitment. Only participants who had signed Informed Consent by then and met eligibility criteria were randomized. 228 participants were randomized to this study.
Participant milestones
| Measure |
Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)
Participants administered 75 mg/m\^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
|
Leuprolide Acetate - Immediate Treatment (I-HT)
Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
|
Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)
Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m\^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months.
|
Leuprolide Acetate - Deferred Treatment (D-HT)
Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
55
|
55
|
56
|
62
|
|
Overall Study
ADMINISTERED STUDY TREATMENT
|
50
|
51
|
20
|
17
|
|
Overall Study
COMPLETED HORMONAL THERAPY (6 Cycles)
|
44
|
48
|
15
|
13
|
|
Overall Study
COMPLETED CHEMOTHERAPY (6 Cycles)
|
43
|
0
|
15
|
0
|
|
Overall Study
COMPLETED
|
43
|
48
|
15
|
13
|
|
Overall Study
NOT COMPLETED
|
12
|
7
|
41
|
49
|
Reasons for withdrawal
| Measure |
Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)
Participants administered 75 mg/m\^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
|
Leuprolide Acetate - Immediate Treatment (I-HT)
Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
|
Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)
Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m\^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months.
|
Leuprolide Acetate - Deferred Treatment (D-HT)
Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months.
|
|---|---|---|---|---|
|
Overall Study
Did not receive any study medication
|
5
|
4
|
36
|
45
|
|
Overall Study
Adverse Event
|
2
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
0
|
|
Overall Study
Progressive disease
|
0
|
0
|
1
|
0
|
|
Overall Study
Participant did not wish to continue
|
3
|
2
|
1
|
0
|
|
Overall Study
Undefined
|
0
|
1
|
1
|
4
|
|
Overall Study
chemotherapy not completed (cycle 6)
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Adjuvant Leuprolide With or Without Docetaxel in High Risk Prostate Cancer After Radical Prostatectomy
Baseline characteristics by cohort
| Measure |
Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)
n=55 Participants
Participants administered 75 mg/m\^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
|
Leuprolide Acetate - Immediate Treatment (I-HT)
n=55 Participants
Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
|
Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)
n=56 Participants
Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m\^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months.
|
Leuprolide Acetate - Deferred Treatment (D-HT)
n=62 Participants
Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months.
|
Total
n=228 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
61.2 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
61.6 years
STANDARD_DEVIATION 7.0 • n=7 Participants
|
62.1 years
STANDARD_DEVIATION 7 • n=5 Participants
|
62.9 years
STANDARD_DEVIATION 7.5 • n=4 Participants
|
61.9 years
STANDARD_DEVIATION 7.2 • n=21 Participants
|
|
Age, Customized
<65 years
|
37 participants
n=5 Participants
|
34 participants
n=7 Participants
|
35 participants
n=5 Participants
|
35 participants
n=4 Participants
|
141 participants
n=21 Participants
|
|
Age, Customized
>=65 years
|
18 participants
n=5 Participants
|
21 participants
n=7 Participants
|
21 participants
n=5 Participants
|
27 participants
n=4 Participants
|
87 participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
228 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
48 participants
n=5 Participants
|
49 participants
n=7 Participants
|
43 participants
n=5 Participants
|
59 participants
n=4 Participants
|
199 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
2 participants
n=4 Participants
|
18 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian/Oriental
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
0 participants
n=4 Participants
|
5 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
4 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: from the date of surgery up to 3 years after randomization of the last participantPopulation: Intent-to-treat (ITT) population: all randomized participants, regardless of whether or not they received any study drug.
PFS is the interval from the date of surgery to date of progression. The date of progression was the earlier of * first PSA increase to ≥ 0.4 ng/mL confirmed within two weeks * date of the nadir, if PSA nadir did not reach \< 0.4 ng/mL (for deferred arm) * first radiological/ histological evidence of tumor progression * death. Median PFS was to be estimated using Kaplan-Meier curves. However, enrollment was not met, and meaningful conclusions for efficacy or QoL could not be drawn. Median PFS could not be estimated. Reported is the number of participants with disease progression.
Outcome measures
| Measure |
Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)
n=55 Participants
Participants administered 75 mg/m\^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
|
Leuprolide Acetate - Immediate Treatment (I-HT)
n=55 Participants
Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
|
Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)
n=56 Participants
Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m\^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months.
|
Leuprolide Acetate - Deferred Treatment (D-HT)
n=62 Participants
Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months.
|
|---|---|---|---|---|
|
Progression-free Survival (PFS) Assessment - Number of Participants With Disease Progression
|
10 participants
|
14 participants
|
9 participants
|
8 participants
|
SECONDARY outcome
Timeframe: from the date of surgery up to 3 years after randomization of the last participantPopulation: Intent-to-treat (ITT) population: all randomized participants, regardless of whether or not they received any drug.
Overall survival (OS) was the time interval from the date of surgery to the date of death due to any cause. Median OS was to be estimated using Kaplan-Meier Curves. However, enrollment was not met, and meaningful conclusions for efficacy or QoL could not be drawn. Moreover, median OS could not be estimated. Reported is the number of participants who died from any cause.
Outcome measures
| Measure |
Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)
n=55 Participants
Participants administered 75 mg/m\^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
|
Leuprolide Acetate - Immediate Treatment (I-HT)
n=55 Participants
Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
|
Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)
n=56 Participants
Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m\^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months.
|
Leuprolide Acetate - Deferred Treatment (D-HT)
n=62 Participants
Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months.
|
|---|---|---|---|---|
|
Median Overall Survival (OS)
|
0 participants
|
2 participants
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: from the date of surgery up to 3 years after randomization of the last participantPopulation: Based on a protocol amendment, analysis for Median CSS was not to be performed as the study was underpowered.
The CSS was the time from the date of surgery to the date of death due to prostate cancer. Median CSS was to be estimated using Kaplan-Meier curves. However, enrollment was not met, and meaningful conclusions for efficacy or QoL could not be drawn. Therefore, based on a protocol amendment, median CSS was not estimated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: from the date of surgery up to 3 years after randomization of the last participantPopulation: Based on a protocol amendment, analysis for Median MFS was not to be performed as the study was underpowered.
MFS was the interval from the date of surgery to the date of the first clinical evidence of metastasis after treatment initiation. Metastasis was evaluated by a physical exam or radiologically on bone scan or CT scan. Local (palpable) progression, documented histologically or by imaging techniques was considered evidence of progression. Median MFS was to be estimated using Kaplan-Meier curves. However, enrollment was not met, and meaningful conclusions for efficacy or QoL could not be drawn. Therefore, based on a protocol amendment, median MFS was not estimated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: from 30 days before randomization (baseline) and 18 months after treatment initiation (for change from baseline)Population: QoL population: The subset of randomized participants who had an evaluable baseline questionnaire and at least one evaluable post-baseline questionnaire. A baseline QoL questionnaire was considered evaluable if it was filled out within 30 days prior to randomization, and no later than the date of randomization.
The FACT-P is a 39-item participant questionnaire which assesses physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and additional prostate cancer specific concerns (12 items). All items are scored from 0 (not at all) to 4 (very much). The total FACT-P score ranges from 0-156, with higher scores representing a better QoL with fewer symptoms. A score of 156 represents the best outcome. Note: Enrollment was not met, and meaningful conclusions for efficacy or QoL could not be drawn due to the low sample size.
Outcome measures
| Measure |
Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)
n=40 Participants
Participants administered 75 mg/m\^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
|
Leuprolide Acetate - Immediate Treatment (I-HT)
n=48 Participants
Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
|
Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)
n=15 Participants
Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m\^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months.
|
Leuprolide Acetate - Deferred Treatment (D-HT)
n=15 Participants
Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months.
|
|---|---|---|---|---|
|
To Evaluate Quality of Life (QoL) as Measured Using a Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire
Baseline
|
124.0 score on a scale
Standard Deviation 6.0
|
121.5 score on a scale
Standard Deviation 17.8
|
114.7 score on a scale
Standard Deviation 13.9
|
119.7 score on a scale
Standard Deviation 15.8
|
|
To Evaluate Quality of Life (QoL) as Measured Using a Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire
Change from Baseline (N=33, N=41, N=12, N=10)
|
0.7 score on a scale
Standard Deviation 12.6
|
1.7 score on a scale
Standard Deviation 17.2
|
6.7 score on a scale
Standard Deviation 15.9
|
6.1 score on a scale
Standard Deviation 18.9
|
SECONDARY outcome
Timeframe: from treatment initiation up to 19 months after treatment initiationPopulation: Safety population: all randomized participants who received any study drug
Number of participants with treatment-emergent adverse events (TEAE). A TEAE was as any adverse event that occurred or worsened during the on-treatment period, which was the period from the day of first infusion of study treatment until 30 days after the last infusion of study treatment.
Outcome measures
| Measure |
Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)
n=50 Participants
Participants administered 75 mg/m\^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
|
Leuprolide Acetate - Immediate Treatment (I-HT)
n=51 Participants
Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
|
Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)
n=20 Participants
Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m\^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months.
|
Leuprolide Acetate - Deferred Treatment (D-HT)
n=17 Participants
Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months.
|
|---|---|---|---|---|
|
Assessment of Safety and Tolerability - Number of Participants With Adverse Events (AE)
with any adverse event (AE)
|
47 participants
|
48 participants
|
19 participants
|
14 participants
|
|
Assessment of Safety and Tolerability - Number of Participants With Adverse Events (AE)
with any serious adverse event (SAE)
|
12 participants
|
8 participants
|
5 participants
|
2 participants
|
|
Assessment of Safety and Tolerability - Number of Participants With Adverse Events (AE)
with an SAE resulting in death
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Assessment of Safety and Tolerability - Number of Participants With Adverse Events (AE)
with a drug-related AE
|
47 participants
|
43 participants
|
18 participants
|
10 participants
|
|
Assessment of Safety and Tolerability - Number of Participants With Adverse Events (AE)
with a drug-related SAE
|
6 participants
|
0 participants
|
2 participants
|
0 participants
|
|
Assessment of Safety and Tolerability - Number of Participants With Adverse Events (AE)
with AE leading to discontinue all study therapy
|
2 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Assessment of Safety and Tolerability - Number of Participants With Adverse Events (AE)
with AE leading to chemotherapy discontinuation
|
1 participants
|
NA participants
Did not receive chemotherapy
|
1 participants
|
NA participants
Did not receive chemotherapy
|
|
Assessment of Safety and Tolerability - Number of Participants With Adverse Events (AE)
with AE leading to chemotherapy dose reduction
|
5 participants
|
NA participants
Did not receive chemotherapy
|
2 participants
|
NA participants
Did not receive chemotherapy
|
Adverse Events
Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)
Serious events: 12 serious events
Other events: 47 other events
Deaths: 0 deaths
Leuprolide Acetate - Immediate Treatment (I-HT)
Serious events: 8 serious events
Other events: 48 other events
Deaths: 0 deaths
Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)
Serious events: 5 serious events
Other events: 19 other events
Deaths: 0 deaths
Leuprolide Acetate - Deferred Treatment (D-HT)
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)
n=50 participants at risk
Participants administered 75 mg/m\^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
|
Leuprolide Acetate - Immediate Treatment (I-HT)
n=51 participants at risk
Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
|
Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)
n=20 participants at risk
Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m\^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months.
|
Leuprolide Acetate - Deferred Treatment (D-HT)
n=17 participants at risk
Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Inguinal hernia
|
2.0%
1/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/50
|
0.00%
0/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/50
|
0.00%
0/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Gastrointestinal disorders
Hernial eventration
|
0.00%
0/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.0%
3/50
|
0.00%
0/51
|
10.0%
2/20
|
0.00%
0/17
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
General disorders
Pyrexia
|
2.0%
1/50
|
0.00%
0/51
|
5.0%
1/20
|
0.00%
0/17
|
|
General disorders
Extravasation
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
General disorders
Fatigue
|
0.00%
0/50
|
0.00%
0/51
|
5.0%
1/20
|
0.00%
0/17
|
|
General disorders
Oedema peripheral
|
0.00%
0/50
|
0.00%
0/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
5.9%
1/17
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/50
|
0.00%
0/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/50
|
0.00%
0/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/50
|
0.00%
0/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/50
|
0.00%
0/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Nervous system disorders
Dizziness
|
0.00%
0/50
|
0.00%
0/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Infections and infestations
Bronchitis
|
0.00%
0/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/50
|
0.00%
0/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Renal and urinary disorders
Renal colic
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Cardiac disorders
Coronary artery disease
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Eye disorders
Optic neuropathy
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/50
|
0.00%
0/51
|
0.00%
0/20
|
5.9%
1/17
|
|
Investigations
Blood glucose increased
|
0.00%
0/50
|
0.00%
0/51
|
0.00%
0/20
|
5.9%
1/17
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/50
|
0.00%
0/51
|
0.00%
0/20
|
5.9%
1/17
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Respiratory tract neoplasm
|
0.00%
0/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
Other adverse events
| Measure |
Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)
n=50 participants at risk
Participants administered 75 mg/m\^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
|
Leuprolide Acetate - Immediate Treatment (I-HT)
n=51 participants at risk
Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
|
Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)
n=20 participants at risk
Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m\^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months.
|
Leuprolide Acetate - Deferred Treatment (D-HT)
n=17 participants at risk
Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/50
|
0.00%
0/51
|
0.00%
0/20
|
5.9%
1/17
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Renal and urinary disorders
Terminal dribbling
|
0.00%
0/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Injury, poisoning and procedural complications
Vascular injury
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Cardiac disorders
Palpitations
|
4.0%
2/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Vascular disorders
Hot flush
|
72.0%
36/50
|
74.5%
38/51
|
55.0%
11/20
|
47.1%
8/17
|
|
Vascular disorders
Hypertension
|
12.0%
6/50
|
3.9%
2/51
|
10.0%
2/20
|
0.00%
0/17
|
|
Vascular disorders
Flushing
|
8.0%
4/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Vascular disorders
Hypotension
|
2.0%
1/50
|
0.00%
0/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Vascular disorders
Intermittent claudication
|
0.00%
0/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/50
|
0.00%
0/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Vascular disorders
Venous insufficiency
|
0.00%
0/50
|
0.00%
0/51
|
0.00%
0/20
|
5.9%
1/17
|
|
General disorders
Fatigue
|
64.0%
32/50
|
31.4%
16/51
|
65.0%
13/20
|
17.6%
3/17
|
|
General disorders
Oedema peripheral
|
24.0%
12/50
|
7.8%
4/51
|
25.0%
5/20
|
0.00%
0/17
|
|
General disorders
Asthenia
|
10.0%
5/50
|
5.9%
3/51
|
25.0%
5/20
|
5.9%
1/17
|
|
General disorders
Pyrexia
|
10.0%
5/50
|
3.9%
2/51
|
0.00%
0/20
|
0.00%
0/17
|
|
General disorders
Induration
|
6.0%
3/50
|
3.9%
2/51
|
5.0%
1/20
|
0.00%
0/17
|
|
General disorders
Mucosal inflammation
|
8.0%
4/50
|
0.00%
0/51
|
5.0%
1/20
|
0.00%
0/17
|
|
General disorders
Pain
|
8.0%
4/50
|
0.00%
0/51
|
5.0%
1/20
|
0.00%
0/17
|
|
General disorders
Chest discomfort
|
6.0%
3/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
General disorders
Chest pain
|
2.0%
1/50
|
0.00%
0/51
|
10.0%
2/20
|
0.00%
0/17
|
|
General disorders
Influenza like illness
|
4.0%
2/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
General disorders
Injection site reaction
|
6.0%
3/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
General disorders
Chills
|
2.0%
1/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
General disorders
Injection site pain
|
0.00%
0/50
|
2.0%
1/51
|
0.00%
0/20
|
5.9%
1/17
|
|
General disorders
Injection site swelling
|
2.0%
1/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
General disorders
Localised oedema
|
4.0%
2/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
General disorders
Tenderness
|
4.0%
2/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
General disorders
Cyst
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
General disorders
Discomfort
|
0.00%
0/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
General disorders
Extravasation
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
General disorders
Face oedema
|
0.00%
0/50
|
0.00%
0/51
|
5.0%
1/20
|
0.00%
0/17
|
|
General disorders
Infusion site extravasation
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
General disorders
Injection site discolouration
|
0.00%
0/50
|
0.00%
0/51
|
5.0%
1/20
|
0.00%
0/17
|
|
General disorders
Injection site discomfort
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
General disorders
Injection site erythema
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
General disorders
Injection site nodule
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
General disorders
Injection site rash
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
General disorders
Necrosis
|
0.00%
0/50
|
0.00%
0/51
|
5.0%
1/20
|
0.00%
0/17
|
|
General disorders
Nodule
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
General disorders
Temperature intolerance
|
0.00%
0/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
General disorders
Thirst
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.0%
6/50
|
13.7%
7/51
|
25.0%
5/20
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.0%
7/50
|
5.9%
3/51
|
25.0%
5/20
|
5.9%
1/17
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
18.0%
9/50
|
7.8%
4/51
|
10.0%
2/20
|
5.9%
1/17
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.0%
4/50
|
9.8%
5/51
|
20.0%
4/20
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.0%
2/50
|
3.9%
2/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.0%
1/50
|
5.9%
3/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/50
|
7.8%
4/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.0%
1/50
|
2.0%
1/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.0%
3/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
2.0%
1/50
|
3.9%
2/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Joint lock
|
0.00%
0/50
|
0.00%
0/51
|
0.00%
0/20
|
5.9%
1/17
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/50
|
0.00%
0/51
|
0.00%
0/20
|
5.9%
1/17
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/50
|
0.00%
0/51
|
0.00%
0/20
|
5.9%
1/17
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/50
|
0.00%
0/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Gastrointestinal disorders
Nausea
|
32.0%
16/50
|
7.8%
4/51
|
20.0%
4/20
|
5.9%
1/17
|
|
Gastrointestinal disorders
Diarrhoea
|
28.0%
14/50
|
3.9%
2/51
|
30.0%
6/20
|
0.00%
0/17
|
|
Gastrointestinal disorders
Constipation
|
20.0%
10/50
|
2.0%
1/51
|
20.0%
4/20
|
0.00%
0/17
|
|
Gastrointestinal disorders
Stomatitis
|
14.0%
7/50
|
0.00%
0/51
|
10.0%
2/20
|
0.00%
0/17
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
5/50
|
2.0%
1/51
|
10.0%
2/20
|
0.00%
0/17
|
|
Gastrointestinal disorders
Dry mouth
|
6.0%
3/50
|
2.0%
1/51
|
10.0%
2/20
|
5.9%
1/17
|
|
Gastrointestinal disorders
Vomiting
|
6.0%
3/50
|
3.9%
2/51
|
10.0%
2/20
|
0.00%
0/17
|
|
Gastrointestinal disorders
Inguinal hernia
|
4.0%
2/50
|
5.9%
3/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Gastrointestinal disorders
Abdominal pain
|
4.0%
2/50
|
2.0%
1/51
|
5.0%
1/20
|
5.9%
1/17
|
|
Gastrointestinal disorders
Dysphagia
|
4.0%
2/50
|
0.00%
0/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Gastrointestinal disorders
Flatulence
|
6.0%
3/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
4.0%
2/50
|
0.00%
0/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.0%
1/50
|
0.00%
0/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Gastrointestinal disorders
Abdominal pain lower
|
2.0%
1/50
|
0.00%
0/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Gastrointestinal disorders
Buccal mucosal roughening
|
4.0%
2/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Gastrointestinal disorders
Gastritis
|
4.0%
2/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Gastrointestinal disorders
Mouth ulceration
|
2.0%
1/50
|
0.00%
0/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
2.0%
1/50
|
0.00%
0/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/50
|
3.9%
2/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Gastrointestinal disorders
Abdominal distension
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Gastrointestinal disorders
Anorectal discomfort
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Gastrointestinal disorders
Glossodynia
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Gastrointestinal disorders
Oral discomfort
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Gastrointestinal disorders
Paraesthesia oral
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Gastrointestinal disorders
Sensitivity of teeth
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Gastrointestinal disorders
Sigmoiditis
|
0.00%
0/50
|
0.00%
0/51
|
0.00%
0/20
|
5.9%
1/17
|
|
Gastrointestinal disorders
Tongue discolouration
|
0.00%
0/50
|
0.00%
0/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
58.0%
29/50
|
0.00%
0/51
|
45.0%
9/20
|
0.00%
0/17
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
28.0%
14/50
|
0.00%
0/51
|
30.0%
6/20
|
0.00%
0/17
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.0%
6/50
|
3.9%
2/51
|
20.0%
4/20
|
0.00%
0/17
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
14.0%
7/50
|
5.9%
3/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
14.0%
7/50
|
2.0%
1/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
6.0%
3/50
|
0.00%
0/51
|
10.0%
2/20
|
0.00%
0/17
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
4.0%
2/50
|
0.00%
0/51
|
5.0%
1/20
|
5.9%
1/17
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.0%
2/50
|
3.9%
2/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/50
|
3.9%
2/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/50
|
0.00%
0/51
|
5.0%
1/20
|
5.9%
1/17
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
0.00%
0/50
|
0.00%
0/51
|
10.0%
2/20
|
0.00%
0/17
|
|
Skin and subcutaneous tissue disorders
Blister
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/50
|
0.00%
0/51
|
0.00%
0/20
|
5.9%
1/17
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/50
|
0.00%
0/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/50
|
0.00%
0/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
0.00%
0/50
|
0.00%
0/51
|
0.00%
0/20
|
5.9%
1/17
|
|
Skin and subcutaneous tissue disorders
Hair disorder
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Skin and subcutaneous tissue disorders
Hair growth abnormal
|
0.00%
0/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis palmaris and plantaris
|
0.00%
0/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Nervous system disorders
Dysgeusia
|
34.0%
17/50
|
0.00%
0/51
|
25.0%
5/20
|
0.00%
0/17
|
|
Nervous system disorders
Headache
|
28.0%
14/50
|
5.9%
3/51
|
15.0%
3/20
|
0.00%
0/17
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
24.0%
12/50
|
3.9%
2/51
|
0.00%
0/20
|
5.9%
1/17
|
|
Nervous system disorders
Dizziness
|
10.0%
5/50
|
3.9%
2/51
|
15.0%
3/20
|
0.00%
0/17
|
|
Nervous system disorders
Paraesthesia
|
12.0%
6/50
|
2.0%
1/51
|
10.0%
2/20
|
0.00%
0/17
|
|
Nervous system disorders
Hypoaesthesia
|
10.0%
5/50
|
0.00%
0/51
|
0.00%
0/20
|
5.9%
1/17
|
|
Nervous system disorders
Neuropathy peripheral
|
4.0%
2/50
|
2.0%
1/51
|
10.0%
2/20
|
0.00%
0/17
|
|
Nervous system disorders
Ageusia
|
4.0%
2/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Nervous system disorders
Burning sensation
|
4.0%
2/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Nervous system disorders
Disturbance in attention
|
4.0%
2/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Nervous system disorders
Amnesia
|
0.00%
0/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Nervous system disorders
Aphasia
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Nervous system disorders
Hyperaesthesia
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Nervous system disorders
Hypogeusia
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Nervous system disorders
Lethargy
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Nervous system disorders
Sciatica
|
0.00%
0/50
|
0.00%
0/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Nervous system disorders
Sensory loss
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Nervous system disorders
Sinus headache
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Nervous system disorders
Tremor
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Renal and urinary disorders
Urinary incontinence
|
30.0%
15/50
|
27.5%
14/51
|
0.00%
0/20
|
11.8%
2/17
|
|
Renal and urinary disorders
Nocturia
|
6.0%
3/50
|
7.8%
4/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Renal and urinary disorders
Pollakiuria
|
4.0%
2/50
|
11.8%
6/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Renal and urinary disorders
Stress urinary incontinence
|
2.0%
1/50
|
5.9%
3/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Renal and urinary disorders
Haematuria
|
2.0%
1/50
|
3.9%
2/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Renal and urinary disorders
Dysuria
|
2.0%
1/50
|
0.00%
0/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Renal and urinary disorders
Urinary retention
|
2.0%
1/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Renal and urinary disorders
Bladder pain
|
0.00%
0/50
|
0.00%
0/51
|
0.00%
0/20
|
5.9%
1/17
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Renal and urinary disorders
Ureteric stenosis
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Renal and urinary disorders
Urethral obstruction
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Renal and urinary disorders
Urinary tract disorder
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
30.0%
15/50
|
33.3%
17/51
|
5.0%
1/20
|
5.9%
1/17
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/50
|
3.9%
2/51
|
10.0%
2/20
|
0.00%
0/17
|
|
Reproductive system and breast disorders
Penile pain
|
0.00%
0/50
|
2.0%
1/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Reproductive system and breast disorders
Ejaculation disorder
|
0.00%
0/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Reproductive system and breast disorders
Genital lesion
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Reproductive system and breast disorders
Nipple pain
|
0.00%
0/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Reproductive system and breast disorders
Oedema genital
|
0.00%
0/50
|
0.00%
0/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Reproductive system and breast disorders
Perineal pain
|
0.00%
0/50
|
0.00%
0/51
|
0.00%
0/20
|
5.9%
1/17
|
|
Reproductive system and breast disorders
Testicular atrophy
|
0.00%
0/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Psychiatric disorders
Insomnia
|
12.0%
6/50
|
9.8%
5/51
|
5.0%
1/20
|
5.9%
1/17
|
|
Psychiatric disorders
Depression
|
6.0%
3/50
|
5.9%
3/51
|
10.0%
2/20
|
5.9%
1/17
|
|
Psychiatric disorders
Mood altered
|
8.0%
4/50
|
5.9%
3/51
|
5.0%
1/20
|
5.9%
1/17
|
|
Psychiatric disorders
Libido decreased
|
4.0%
2/50
|
7.8%
4/51
|
0.00%
0/20
|
11.8%
2/17
|
|
Psychiatric disorders
Anxiety
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
5.9%
1/17
|
|
Psychiatric disorders
Affect lability
|
0.00%
0/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Psychiatric disorders
Claustrophobia
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Psychiatric disorders
Emotional distress
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Psychiatric disorders
Nervousness
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Psychiatric disorders
Sleep disorder
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Infections and infestations
Infection
|
8.0%
4/50
|
2.0%
1/51
|
0.00%
0/20
|
5.9%
1/17
|
|
Infections and infestations
Bronchitis
|
2.0%
1/50
|
2.0%
1/51
|
0.00%
0/20
|
5.9%
1/17
|
|
Infections and infestations
Sinusitis
|
2.0%
1/50
|
3.9%
2/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Infections and infestations
Herpes zoster
|
2.0%
1/50
|
0.00%
0/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Infections and infestations
Hordeolum
|
2.0%
1/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Infections and infestations
Nasopharyngitis
|
2.0%
1/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Infections and infestations
Neutropenic infection
|
4.0%
2/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/50
|
3.9%
2/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Infections and infestations
Rhinitis
|
2.0%
1/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
1/50
|
0.00%
0/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/50
|
2.0%
1/51
|
0.00%
0/20
|
5.9%
1/17
|
|
Infections and infestations
Abscess
|
0.00%
0/50
|
0.00%
0/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Infections and infestations
Anal infection
|
0.00%
0/50
|
0.00%
0/51
|
0.00%
0/20
|
5.9%
1/17
|
|
Infections and infestations
Campylobacter intestinal infection
|
0.00%
0/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Infections and infestations
Cellulitis
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Infections and infestations
Erysipelas
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Infections and infestations
Eye infection
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Infections and infestations
Genital infection fungal
|
0.00%
0/50
|
0.00%
0/51
|
0.00%
0/20
|
5.9%
1/17
|
|
Infections and infestations
Herpes simplex
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Infections and infestations
Herpes simplex ophthalmic
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Infections and infestations
Influenza
|
0.00%
0/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Infections and infestations
Lip infection
|
0.00%
0/50
|
0.00%
0/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Infections and infestations
Oral candidiasis
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Infections and infestations
Otitis externa
|
0.00%
0/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Infections and infestations
Pyelonephritis
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Infections and infestations
Skin candida
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Infections and infestations
Viral infection
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Investigations
Weight increased
|
12.0%
6/50
|
15.7%
8/51
|
15.0%
3/20
|
11.8%
2/17
|
|
Investigations
Blood glucose increased
|
2.0%
1/50
|
2.0%
1/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Investigations
Weight decreased
|
4.0%
2/50
|
0.00%
0/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Investigations
Blood urea increased
|
4.0%
2/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Investigations
Cardiac murmur
|
2.0%
1/50
|
0.00%
0/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/50
|
0.00%
0/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Investigations
Blood pressure increased
|
0.00%
0/50
|
0.00%
0/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Investigations
Blood urine
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Investigations
Body temperature fluctuation
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Investigations
Bone density decreased
|
0.00%
0/50
|
0.00%
0/51
|
0.00%
0/20
|
5.9%
1/17
|
|
Investigations
Gamma-glutamyltransferase
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.0%
6/50
|
2.0%
1/51
|
15.0%
3/20
|
0.00%
0/17
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.0%
3/50
|
3.9%
2/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
10.0%
5/50
|
0.00%
0/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.0%
4/50
|
0.00%
0/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.0%
3/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Respiratory, thoracic and mediastinal disorders
Nasal disorder
|
0.00%
0/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Eye disorders
Lacrimation increased
|
8.0%
4/50
|
0.00%
0/51
|
10.0%
2/20
|
0.00%
0/17
|
|
Eye disorders
Vision blurred
|
8.0%
4/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Eye disorders
Eye pain
|
4.0%
2/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Eye disorders
Ocular hyperaemia
|
4.0%
2/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Eye disorders
Blepharitis
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Eye disorders
Cataract
|
0.00%
0/50
|
0.00%
0/51
|
0.00%
0/20
|
5.9%
1/17
|
|
Eye disorders
Conjunctivitis
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Eye disorders
Eye haemorrhage
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Eye disorders
Eye pruritus
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Eye disorders
Eyelid oedema
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Eye disorders
Glaucoma
|
0.00%
0/50
|
0.00%
0/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Eye disorders
Keratoconjunctivitis sicca
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Eye disorders
Lacrimal disorder
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Eye disorders
Optic neuropathy
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Eye disorders
Retinal detachment
|
0.00%
0/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Eye disorders
Retinopathy
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.0%
4/50
|
3.9%
2/51
|
10.0%
2/20
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
8.0%
4/50
|
3.9%
2/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
4.0%
2/50
|
0.00%
0/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Increased appetite
|
2.0%
1/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/50
|
0.00%
0/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/50
|
0.00%
0/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Injury, poisoning and procedural complications
Foot fracture
|
2.0%
1/50
|
0.00%
0/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Injury, poisoning and procedural complications
Procedural complication
|
4.0%
2/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Injury, poisoning and procedural complications
Contusion
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Injury, poisoning and procedural complications
Excoriation
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Injury, poisoning and procedural complications
Eye penetration
|
0.00%
0/50
|
0.00%
0/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/50
|
0.00%
0/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Injury, poisoning and procedural complications
Nail avulsion
|
0.00%
0/50
|
0.00%
0/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Cardiac disorders
Diastolic dysfunction
|
0.00%
0/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Cardiac disorders
Nodal arrhythmia
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Cardiac disorders
Sinus tachycardia
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Ear and labyrinth disorders
Tinnitus
|
2.0%
1/50
|
2.0%
1/51
|
0.00%
0/20
|
5.9%
1/17
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.0%
1/50
|
0.00%
0/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Blood and lymphatic system disorders
Lymphopenia
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/50
|
0.00%
0/51
|
0.00%
0/20
|
5.9%
1/17
|
|
Immune system disorders
Hypersensitivity
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Immune system disorders
Multiple allergies
|
0.00%
0/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.00%
0/50
|
2.0%
1/51
|
0.00%
0/20
|
0.00%
0/17
|
|
Congenital, familial and genetic disorders
Thalassaemia
|
0.00%
0/50
|
0.00%
0/51
|
5.0%
1/20
|
0.00%
0/17
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
0.00%
0/50
|
0.00%
0/51
|
0.00%
0/20
|
5.9%
1/17
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/20
|
0.00%
0/17
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator shall provide the Steering Committee a copy of any manuscript, abstract or oral communication derived from the study for review and comment at least 30 days in advance of any submission. The Sponsor's representatives shall have the right to review and/or delay any publication or presentation to prevent disclosure of Sponsor's confidential information and preserve intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER