Trial Outcomes & Findings for Evaluation of Safety and Feasibility of OGX-011 in Combination With 2nd-line Chemotherapy in Patients With HRPC (NCT NCT00327340)
NCT ID: NCT00327340
Last Updated: 2012-10-05
Results Overview
Safety and tolerability were based on Adverse Events (AE) and Serious Adverse Events (SAE) graded using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE). The CTCAE has 5 grades with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1=Mild AE; Grade 2=Moderate AE; Grade 3=Severe AE; Grade 4=Life-threatening or disabling AE; and Grade 5=Death related to AE.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
70 participants
Primary outcome timeframe
Subjects were followed for safety from enrollment for up to 8 months (9 three-week cycles plus 30 days after end of treatment)
Results posted on
2012-10-05
Participant Flow
Participants were recruited at 10 institutions with a primary focus in oncology and located in Canada. The first subject was randomized on July 25, 2006. The last subject completed treatment on August 6, 2008 and the last survival follow-up visit was on August 13, 2010
A total of 70 subjects were enrolled. 45 subjects were randomly assigned to treatment (21 to OGX-011/ docetaxel and 24 OGX-011/ mitoxantrone). An additional 25 subjects were enrolled under Amendment 2 and assigned to OGX-011/docetaxel retreatment. One subject was found to be ineligible and was not treated.
Participant milestones
| Measure |
OGX-011 / Mitoxantrone/Prednisone
All subjects began with oral prednisone (5 mg twice daily)on Day-10. Custirsen (OGX-011) was infused intravenously over 2 hours on Day -7, -5 and-3 of cycle 1 (Pretreatment loading doses). OGX-011 was then infused for 2 hours on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone was infused at a dose of 12 mg/m² over 30 minutes on day 1 of each cycle.
|
OGX-011 / Docetaxel/Prednisone
All subjects began with oral prednisone (5 mg twice daily)on Day-10. Custirsen (OGX-011) was infused intravenously over 2 hours on Day -7, -5 and -3 of cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours on Days 1, 8, and 15 of each 21-day cycle. Docetaxel was infused at a dose of 75 mg/m² over 60 minutes on day 1 of each cycle.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
46
|
|
Overall Study
COMPLETED
|
8
|
16
|
|
Overall Study
NOT COMPLETED
|
15
|
30
|
Reasons for withdrawal
| Measure |
OGX-011 / Mitoxantrone/Prednisone
All subjects began with oral prednisone (5 mg twice daily)on Day-10. Custirsen (OGX-011) was infused intravenously over 2 hours on Day -7, -5 and-3 of cycle 1 (Pretreatment loading doses). OGX-011 was then infused for 2 hours on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone was infused at a dose of 12 mg/m² over 30 minutes on day 1 of each cycle.
|
OGX-011 / Docetaxel/Prednisone
All subjects began with oral prednisone (5 mg twice daily)on Day-10. Custirsen (OGX-011) was infused intravenously over 2 hours on Day -7, -5 and -3 of cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours on Days 1, 8, and 15 of each 21-day cycle. Docetaxel was infused at a dose of 75 mg/m² over 60 minutes on day 1 of each cycle.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
5
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Disease Progression
|
10
|
19
|
|
Overall Study
Symptomatic Disease
|
0
|
2
|
|
Overall Study
Adverse Event
|
3
|
3
|
Baseline Characteristics
Evaluation of Safety and Feasibility of OGX-011 in Combination With 2nd-line Chemotherapy in Patients With HRPC
Baseline characteristics by cohort
| Measure |
OGX-011 / Mitoxantrone/Prednisone
n=23 Participants
All subjects began with oral prednisone (5 mg twice daily)on Day-10. Custirsen (OGX-011) was infused intravenously over 2 hours on Day -7, -5 and-3 of cycle 1 (Pretreatment loading doses). OGX-011 was then infused for 2 hours on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone was infused at a dose of 12 mg/m² over 30 minutes on day 1 of each cycle.
|
OGX-011 / Docetaxel/Prednisone
n=46 Participants
All subjects began with oral prednisone (5 mg twice daily)on Day-10. Custirsen (OGX-011) was infused intravenously over 2 hours on Day -7, -5 and -3 of cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours on Days 1, 8, and 15 of each 21-day cycle. Docetaxel was infused at a dose of 75 mg/m² over 60 minutes on day 1 of each cycle.
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
61 years
n=5 Participants
|
64 years
n=7 Participants
|
63 years
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
|
23 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Karnofsky Score
60-70%
|
2 participants
n=5 Participants
|
6 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Karnofsky Score
80%
|
7 participants
n=5 Participants
|
13 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Karnofsky Score
90%
|
7 participants
n=5 Participants
|
22 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Karnofsky Score
100%
|
7 participants
n=5 Participants
|
5 participants
n=7 Participants
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Subjects were followed for safety from enrollment for up to 8 months (9 three-week cycles plus 30 days after end of treatment)Population: The total analysis population was 69 subjects: 70 subjects were enrolled; 45 were randomly assigned to treatment (24 to OGX-011/mitoxantrone and 21 to OGX-011 /docetaxel). An additional 25 subjects were assigned to OGX-011/docetaxel. One subject in the mitoxantrone arm was ineligible and did not receive study treatment.
Safety and tolerability were based on Adverse Events (AE) and Serious Adverse Events (SAE) graded using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE). The CTCAE has 5 grades with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1=Mild AE; Grade 2=Moderate AE; Grade 3=Severe AE; Grade 4=Life-threatening or disabling AE; and Grade 5=Death related to AE.
Outcome measures
| Measure |
OGX-011 + Mitoxantrone + Prednisone
n=23 Participants
custirsen (OGX-011) in combination with mitoxantrone and prednisone
|
OGX-011 + Docetaxel + Prednisone
n=46 Participants
custirsen (OGX-011) in combination with docetaxel and prednisone
|
|---|---|---|
|
Safety and Tolerability of Custirsen (OGX-011) in Combination With Either Docetaxel/Prednisone or Mitoxantrone/Prednisone as Second-line Chemotherapy.
Percent of Subjects with Serious Adverse Events
|
26 percentage of participants
|
26 percentage of participants
|
|
Safety and Tolerability of Custirsen (OGX-011) in Combination With Either Docetaxel/Prednisone or Mitoxantrone/Prednisone as Second-line Chemotherapy.
Percent of Subjects with Grade 5 Adverse Events
|
13 percentage of participants
|
4 percentage of participants
|
|
Safety and Tolerability of Custirsen (OGX-011) in Combination With Either Docetaxel/Prednisone or Mitoxantrone/Prednisone as Second-line Chemotherapy.
Percent of Subjects with Grade 4 Adverse Events
|
26 percentage of participants
|
15 percentage of participants
|
|
Safety and Tolerability of Custirsen (OGX-011) in Combination With Either Docetaxel/Prednisone or Mitoxantrone/Prednisone as Second-line Chemotherapy.
Percent of Subjects with Grade 3 Adverse Events
|
70 percentage of participants
|
52 percentage of participants
|
|
Safety and Tolerability of Custirsen (OGX-011) in Combination With Either Docetaxel/Prednisone or Mitoxantrone/Prednisone as Second-line Chemotherapy.
Percent of Subjects with Grade 2 Adverse Events
|
83 percentage of participants
|
98 percentage of participants
|
|
Safety and Tolerability of Custirsen (OGX-011) in Combination With Either Docetaxel/Prednisone or Mitoxantrone/Prednisone as Second-line Chemotherapy.
Percent of Subjects with Grade 1 Adverse Events
|
100 percentage of participants
|
100 percentage of participants
|
|
Safety and Tolerability of Custirsen (OGX-011) in Combination With Either Docetaxel/Prednisone or Mitoxantrone/Prednisone as Second-line Chemotherapy.
Percent of Subjects who Discontinued Study Drug
|
22 percentage of participants
|
17 percentage of participants
|
SECONDARY outcome
Timeframe: PSA was evaluated at screening, on Day 1 of each cycle, at the end of treatment visit and during off-treatment follow up (up to 27 months)Population: Subjects were evaluable for PSA response if they had baseline PSA and at least two post baseline PSA values. One subject was not evaluable for PSA response; he had only one post baseline PSA value. A PSA response was defined in the protocol as a decrease in PSA of ≥ 50% relative to baseline on two or more consecutive measurements 4-6 weeks apart.
PSA or prostate specific antigen is a marker for prostate cancer. A PSA response was defined as a decrease in PSA values of ≥ 50% relative to baseline on two or more consecutive measurements that were 4-6 weeks apart.
Outcome measures
| Measure |
OGX-011 + Mitoxantrone + Prednisone
n=23 Participants
custirsen (OGX-011) in combination with mitoxantrone and prednisone
|
OGX-011 + Docetaxel + Prednisone
n=45 Participants
custirsen (OGX-011) in combination with docetaxel and prednisone
|
|---|---|---|
|
Feasibility of Treatment With Custirsen (OGX-011) in Combination With Second-line Chemotherapy Based on Prostate Specific Antigen (PSA) Response
|
17 percentage of participants
Interval 5.0 to 38.8
|
31 percentage of participants
Interval 18.2 to 46.6
|
SECONDARY outcome
Timeframe: Enrollment until pain progression (up to 21 months)Population: Subjects were evaluable for pain response if they had a baseline Worst Pain Score ≥ 2 or were on opioid analgesics at baseline.
Time to pain progression was defined as the time (months) from the first dose of OGX-011 to the first documentation of pain or analgesic progression or initiation of palliative radiation therapy. Pain response was defined as either a decrease of at least two points on the 11-point Worst Pain Scale, without an increase in analgesic level, maintained for at least two consecutive measurements approximately three weeks apart -or- a decrease in analgesic level, without an increase in pain score, maintained for at least two consecutive measurements approximately three weeks apart.
Outcome measures
| Measure |
OGX-011 + Mitoxantrone + Prednisone
n=18 Participants
custirsen (OGX-011) in combination with mitoxantrone and prednisone
|
OGX-011 + Docetaxel + Prednisone
n=20 Participants
custirsen (OGX-011) in combination with docetaxel and prednisone
|
|---|---|---|
|
Feasibility of Treatment With OGX-011 in Combination With Either Docetaxel/Prednisone or Mitoxantrone/Prednisone as Second Line Chemotherapy Based on Time to Pain Progression
|
5.2 months
Interval 1.6 to 8.1
|
7.2 months
Interval 5.8 to 10.6
|
SECONDARY outcome
Timeframe: Enrollment until disease progression (up to 13 months)Population: All 69 subjects were included. Data are presented for the 20 subjects who achieved a 50% decline in PSA (6 subjects who received mitoxantrone and prednisone in combination with OGX-011 and 14 subjects who received docetaxel and prednisone in combination with OGX-011)
Serum clusterin samples were collected prior to receiving OGX-011 loading dose 1, prior to study treatment on Day 1 of each cycle, and at the end of treatment. PSA was evaluated at screening, on Day 1 of each cycle, at the end of treatment visit, and during off-treatment follow-up. PSA response was defined in the protocol as a decrease in PSA of ≥ 50% relative to baseline on two or more consecutive measurements 4-6 weeks apart.
Outcome measures
| Measure |
OGX-011 + Mitoxantrone + Prednisone
n=23 Participants
custirsen (OGX-011) in combination with mitoxantrone and prednisone
|
OGX-011 + Docetaxel + Prednisone
n=46 Participants
custirsen (OGX-011) in combination with docetaxel and prednisone
|
|---|---|---|
|
Relationship Between Changes in Serum Clusterin Levels and Change in Serum PSA Levels When OGX-011 in Combination With Either Docetaxel/Prednisone or Mitoxantrone/Prednisone is Administered as Second Line Chemotherapy.
Minimum clusterin level < or = to 45 mcg/mL
|
22 percentage of participants
|
24 percentage of participants
|
|
Relationship Between Changes in Serum Clusterin Levels and Change in Serum PSA Levels When OGX-011 in Combination With Either Docetaxel/Prednisone or Mitoxantrone/Prednisone is Administered as Second Line Chemotherapy.
Minimum clusterin level > 45 mcg/mL
|
4 percentage of participants
|
7 percentage of participants
|
Adverse Events
OGX-011 / Mitoxantrone/Prednisone
Serious events: 6 serious events
Other events: 23 other events
Deaths: 0 deaths
OGX-011 / Docetaxel/Prednisone
Serious events: 12 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
OGX-011 / Mitoxantrone/Prednisone
n=23 participants at risk
All subjects began with oral prednisone (5 mg twice daily)on Day-10. Custirsen (OGX-011) was infused intravenously over 2 hours on Day -7, -5 and-3 of cycle 1 (Pretreatment loading doses). OGX-011 was then infused for 2 hours on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone was infused at a dose of 12 mg/m² over 30 minutes on day 1 of each cycle.
|
OGX-011 / Docetaxel/Prednisone
n=46 participants at risk
All subjects began with oral prednisone (5 mg twice daily)on Day-10. Custirsen (OGX-011) was infused intravenously over 2 hours on Day -7, -5 and -3 of cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours on Days 1, 8, and 15 of each 21-day cycle. Docetaxel was infused at a dose of 75 mg/m² over 60 minutes on day 1 of each cycle.
|
|---|---|---|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/23
|
2.2%
1/46
|
|
Infections and infestations
Klebsiella Sepsis
|
0.00%
0/23
|
2.2%
1/46
|
|
Infections and infestations
Pneumonia
|
0.00%
0/23
|
2.2%
1/46
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/23
|
2.2%
1/46
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/23
|
2.2%
1/46
|
|
Infections and infestations
Septic Shock
|
4.3%
1/23
|
0.00%
0/46
|
|
Gastrointestinal disorders
Acute Abdomen
|
0.00%
0/23
|
2.2%
1/46
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/23
|
2.2%
1/46
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/23
|
2.2%
1/46
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/23
|
2.2%
1/46
|
|
General disorders
Asthenia
|
4.3%
1/23
|
2.2%
1/46
|
|
General disorders
Death
|
0.00%
0/23
|
2.2%
1/46
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/23
|
2.2%
1/46
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/23
|
2.2%
1/46
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
4.3%
1/23
|
2.2%
1/46
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/23
|
2.2%
1/46
|
|
Cardiac disorders
Cardiac Failure
|
4.3%
1/23
|
0.00%
0/46
|
|
Metabolism and nutrition disorders
Dehydration
|
4.3%
1/23
|
2.2%
1/46
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Meninges
|
0.00%
0/23
|
2.2%
1/46
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer Metastatic
|
4.3%
1/23
|
0.00%
0/46
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/23
|
2.2%
1/46
|
|
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Oedema
|
4.3%
1/23
|
0.00%
0/46
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
4.3%
1/23
|
0.00%
0/46
|
Other adverse events
| Measure |
OGX-011 / Mitoxantrone/Prednisone
n=23 participants at risk
All subjects began with oral prednisone (5 mg twice daily)on Day-10. Custirsen (OGX-011) was infused intravenously over 2 hours on Day -7, -5 and-3 of cycle 1 (Pretreatment loading doses). OGX-011 was then infused for 2 hours on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone was infused at a dose of 12 mg/m² over 30 minutes on day 1 of each cycle.
|
OGX-011 / Docetaxel/Prednisone
n=46 participants at risk
All subjects began with oral prednisone (5 mg twice daily)on Day-10. Custirsen (OGX-011) was infused intravenously over 2 hours on Day -7, -5 and -3 of cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours on Days 1, 8, and 15 of each 21-day cycle. Docetaxel was infused at a dose of 75 mg/m² over 60 minutes on day 1 of each cycle.
|
|---|---|---|
|
General disorders
Fatigue
|
78.3%
18/23
|
69.6%
32/46
|
|
General disorders
Oedema Peripheral
|
43.5%
10/23
|
45.7%
21/46
|
|
General disorders
Chills
|
43.5%
10/23
|
41.3%
19/46
|
|
General disorders
Pyrexia
|
60.9%
14/23
|
30.4%
14/46
|
|
General disorders
Asthenia
|
13.0%
3/23
|
15.2%
7/46
|
|
General disorders
Chest Pain
|
13.0%
3/23
|
0.00%
0/46
|
|
General disorders
Mucosal Inflammation
|
13.0%
3/23
|
0.00%
0/46
|
|
General disorders
Pain
|
17.4%
4/23
|
2.2%
1/46
|
|
Gastrointestinal disorders
Nausea
|
60.9%
14/23
|
50.0%
23/46
|
|
Gastrointestinal disorders
Vomiting
|
43.5%
10/23
|
34.8%
16/46
|
|
Gastrointestinal disorders
Diarrhoea
|
21.7%
5/23
|
41.3%
19/46
|
|
Gastrointestinal disorders
Constipation
|
17.4%
4/23
|
21.7%
10/46
|
|
Gastrointestinal disorders
Abdominal Pain
|
26.1%
6/23
|
6.5%
3/46
|
|
Gastrointestinal disorders
Stomatitis
|
8.7%
2/23
|
8.7%
4/46
|
|
Gastrointestinal disorders
Abdominal Distension
|
8.7%
2/23
|
4.3%
2/46
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/23
|
6.5%
3/46
|
|
Gastrointestinal disorders
Dysphagia
|
17.4%
4/23
|
0.00%
0/46
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
21.7%
5/23
|
26.1%
12/46
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
26.1%
6/23
|
21.7%
10/46
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
30.4%
7/23
|
17.4%
8/46
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
21.7%
5/23
|
13.0%
6/46
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
13.0%
3/23
|
10.9%
5/46
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/23
|
13.0%
6/46
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/23
|
8.7%
4/46
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
13.0%
3/23
|
4.3%
2/46
|
|
Nervous system disorders
Neuropathy Peripheral
|
13.0%
3/23
|
28.3%
13/46
|
|
Nervous system disorders
Dysgeusia
|
13.0%
3/23
|
26.1%
12/46
|
|
Nervous system disorders
Dizziness
|
13.0%
3/23
|
23.9%
11/46
|
|
Nervous system disorders
Headache
|
30.4%
7/23
|
8.7%
4/46
|
|
Nervous system disorders
Hypoaesthesia
|
8.7%
2/23
|
6.5%
3/46
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
0.00%
0/23
|
6.5%
3/46
|
|
Nervous system disorders
Tremor
|
8.7%
2/23
|
0.00%
0/46
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/23
|
6.5%
3/46
|
|
Nervous system disorders
Syncope
|
0.00%
0/23
|
6.5%
3/46
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
26.1%
6/23
|
23.9%
11/46
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
34.8%
8/23
|
13.0%
6/46
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
8.7%
2/23
|
6.5%
3/46
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/23
|
6.5%
3/46
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
0.00%
0/23
|
6.5%
3/46
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/23
|
6.5%
3/46
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
52.2%
12/23
|
34.8%
16/46
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/23
|
8.7%
4/46
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/23
|
19.6%
9/46
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/23
|
10.9%
5/46
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/23
|
8.7%
4/46
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.3%
1/23
|
6.5%
3/46
|
|
Infections and infestations
Oral Herpes
|
4.3%
1/23
|
6.5%
3/46
|
|
Infections and infestations
Nasopharyngitis
|
8.7%
2/23
|
4.3%
2/46
|
|
Investigations
Weight Decreased
|
26.1%
6/23
|
17.4%
8/46
|
|
Investigations
Aspartate Aminotransferase Increased
|
8.7%
2/23
|
0.00%
0/46
|
|
Psychiatric disorders
Insomnia
|
34.8%
8/23
|
10.9%
5/46
|
|
Psychiatric disorders
Anxiety
|
17.4%
4/23
|
13.0%
6/46
|
|
Psychiatric disorders
Depression
|
8.7%
2/23
|
8.7%
4/46
|
|
Psychiatric disorders
Confused State
|
8.7%
2/23
|
2.2%
1/46
|
|
Psychiatric disorders
Mood Altered
|
8.7%
2/23
|
0.00%
0/46
|
|
Blood and lymphatic system disorders
Anaemia
|
34.8%
8/23
|
17.4%
8/46
|
|
Blood and lymphatic system disorders
Neutropenia
|
8.7%
2/23
|
8.7%
4/46
|
|
Vascular disorders
Hypotension
|
4.3%
1/23
|
10.9%
5/46
|
|
Vascular disorders
Hot Flush
|
17.4%
4/23
|
2.2%
1/46
|
|
Injury, poisoning and procedural complications
Contusion
|
4.3%
1/23
|
13.0%
6/46
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/23
|
6.5%
3/46
|
|
Eye disorders
Lacrimation Increased
|
4.3%
1/23
|
17.4%
8/46
|
|
Renal and urinary disorders
Haematuria
|
4.3%
1/23
|
6.5%
3/46
|
|
Renal and urinary disorders
Pollakiuria
|
8.7%
2/23
|
2.2%
1/46
|
|
Renal and urinary disorders
Nocturia
|
8.7%
2/23
|
0.00%
0/46
|
|
Reproductive system and breast disorders
Pelvic Pain
|
8.7%
2/23
|
4.3%
2/46
|
|
Cardiac disorders
Atrial Fibrillation
|
8.7%
2/23
|
2.2%
1/46
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All investigators had an agreement with the Canadian Urological Oncology Group (CUOG). The investigators were to provide CUOG with text to be presented or published 45 days prior to the release for review. Results from one institution were not to be presented before the multi-center publication. If there is no multi-center publication within 12 months after the Study completion the Investigator had the right to publish the results.
- Publication restrictions are in place
Restriction type: OTHER