Trial Outcomes & Findings for Abiraterone Acetate Plus LHRH Agonist and Abiraterone Acetate Plus LHRH Agonist and Enzalutamide (NCT NCT01946165)
NCT ID: NCT01946165
Last Updated: 2019-12-06
Results Overview
The proportion of participants with pathologic stage less than or equal to ypT2N0 will be descriptively summarized and compared between the two treatment arms. The proportion will be calculated as the number of patients with less than or equal to ypT2N0 in each treatment arm divided by the total number of patients who underwent surgery in the same arm.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
69 participants
Primary outcome timeframe
For all participants who underwent surgery, from start of treatment until surgery is completed
Results posted on
2019-12-06
Participant Flow
Patients with prostate cancer at high-risk for recurrence randomized to two treatment groups
Out of 69 participants, due to a screen failure, no arm assignment was made for 1 participant; therefore, only 68 participants were treated and evaluable for outcome analysis.
Participant milestones
| Measure |
Group A: Abiraterone + Enzalutamide + LHRHa + Prednisone.
Patients receive abiraterone acetate (1,000 mg daily) plus prednisone (5mg once daily) and LHRHa. Patients receive a LHRHa (monthly injection or three-month injection) for a maximum of 7 months before a prostatectomy is performed. Study doctor will decide what hormone therapy patient receives.
Abiraterone Acetate: 1,000 mg by mouth daily for each 28 day cycle.
Prednisone: 5 mg by mouth once daily for each 28 day cycle.
Enzalutamide: 160 mg by mouth daily for each 28 day cycle.
LHRHa: Patients receive a LHRHa (monthly injection or three-month injection) for a maximum of 7 months before a prostatectomy is performed. Study doctor will decide what hormone therapy patient receives.
|
Group B: Abiraterone + LHRHa + Prednisone.
Patients receive abiraterone acetate (1,000 mg daily) plus prednisone (5mg once daily) and LHRHa. Patients receive a LHRHa (monthly injection or three-month injection) for a maximum of 7 months before a prostatectomy is performed. Study doctor will decide what hormone therapy patient receives.
Abiraterone Acetate: 1,000 mg by mouth daily for each 28 day cycle.
Prednisone: 5 mg by mouth once daily for each 28 day cycle.
LHRHa: Patients receive a LHRHa (monthly injection or three-month injection) for a maximum of 7 months before a prostatectomy is performed. Study doctor will decide what hormone therapy patient receives.
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
23
|
|
Overall Study
COMPLETED
|
43
|
21
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Group A: Abiraterone + Enzalutamide + LHRHa + Prednisone.
Patients receive abiraterone acetate (1,000 mg daily) plus prednisone (5mg once daily) and LHRHa. Patients receive a LHRHa (monthly injection or three-month injection) for a maximum of 7 months before a prostatectomy is performed. Study doctor will decide what hormone therapy patient receives.
Abiraterone Acetate: 1,000 mg by mouth daily for each 28 day cycle.
Prednisone: 5 mg by mouth once daily for each 28 day cycle.
Enzalutamide: 160 mg by mouth daily for each 28 day cycle.
LHRHa: Patients receive a LHRHa (monthly injection or three-month injection) for a maximum of 7 months before a prostatectomy is performed. Study doctor will decide what hormone therapy patient receives.
|
Group B: Abiraterone + LHRHa + Prednisone.
Patients receive abiraterone acetate (1,000 mg daily) plus prednisone (5mg once daily) and LHRHa. Patients receive a LHRHa (monthly injection or three-month injection) for a maximum of 7 months before a prostatectomy is performed. Study doctor will decide what hormone therapy patient receives.
Abiraterone Acetate: 1,000 mg by mouth daily for each 28 day cycle.
Prednisone: 5 mg by mouth once daily for each 28 day cycle.
LHRHa: Patients receive a LHRHa (monthly injection or three-month injection) for a maximum of 7 months before a prostatectomy is performed. Study doctor will decide what hormone therapy patient receives.
|
|---|---|---|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Abiraterone Acetate Plus LHRH Agonist and Abiraterone Acetate Plus LHRH Agonist and Enzalutamide
Baseline characteristics by cohort
| Measure |
Group A: Abiraterone + Enzalutamide+ LHRHa+ Prednisone
n=45 Participants
Patients receive abiraterone acetate (1,000 mg daily) plus prednisone (5mg once daily) in combination with enzalutamide (160 mg daily) and LHRHa. Patients receive a LHRHa (monthly injection or three-month injection) for a maximum of 7 months before a prostatectomy is performed. Study doctor will decide what hormone therapy patient receives.
Abiraterone Acetate: 1,000 mg by mouth daily for each 28 day cycle.
Prednisone: 5 mg by mouth once daily for each 28 day cycle.
Enzalutamide: 160 mg by mouth daily for each 28 day cycle.
LHRHa: Patients receive a LHRHa (monthly injection or three-month injection) for a maximum of 7 months before a prostatectomy is performed. Study doctor will decide what hormone therapy patient receives.
|
Group B: Abiraterone+ LHRHa+ Prednisone
n=23 Participants
Patients receive abiraterone acetate (1,000 mg daily) plus prednisone (5mg once daily) and LHRHa. Patients receive a LHRHa (monthly injection or three-month injection) for a maximum of 7 months before a prostatectomy is performed. Study doctor will decide what hormone therapy patient receives.
Abiraterone Acetate: 1,000 mg by mouth daily for each 28 day cycle.
Prednisone: 5 mg by mouth once daily for each 28 day cycle.
LHRHa: Patients receive a LHRHa (monthly injection or three-month injection) for a maximum of 7 months before a prostatectomy is performed. Study doctor will decide what hormone therapy patient receives.
|
Total
n=68 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
|
24 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
21 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Age, Continuous
|
66 years
n=5 Participants
|
64 years
n=7 Participants
|
65 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
|
45 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
68 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
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 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
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
48 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
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
45 participants
n=5 Participants
|
23 participants
n=7 Participants
|
68 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: For all participants who underwent surgery, from start of treatment until surgery is completedPopulation: Patients that are evaluable are included in these values.
The proportion of participants with pathologic stage less than or equal to ypT2N0 will be descriptively summarized and compared between the two treatment arms. The proportion will be calculated as the number of patients with less than or equal to ypT2N0 in each treatment arm divided by the total number of patients who underwent surgery in the same arm.
Outcome measures
| Measure |
Group B: Abiraterone + LHRHa + Prednisone
n=21 Participants
Patients receive abiraterone acetate (1,000 mg daily) plus prednisone (5mg once daily) and LHRHa. Patients receive a LHRHa (monthly injection or three-month injection) for a maximum of 7 months before a prostatectomy is performed. Study doctor will decide what hormone therapy patient receives.
Abiraterone Acetate: 1,000 mg by mouth daily for each 28 day cycle.
Prednisone: 5 mg by mouth once daily for each 28 day cycle.
LHRHa: Patients receive a LHRHa (monthly injection or three-month injection) for a maximum of 7 months before a prostatectomy is performed. Study doctor will decide what hormone therapy patient receives.
|
Group A: Abiraterone + Enzalutamide + LHRHa + Prednisone.
n=43 Participants
Patients receive abiraterone acetate (1,000 mg daily) plus prednisone (5mg once daily) in combination with enzalutamide (160 mg daily) and LHRHa. Patients receive a LHRHa (monthly injection or three-month injection) for a maximum of 7 months before a prostatectomy is performed. Study doctor will decide what hormone therapy patient receives.
Abiraterone Acetate: 1,000 mg by mouth daily for each 28 day cycle.
Prednisone: 5 mg by mouth once daily for each 28 day cycle.
Enzalutamide: 160 mg by mouth daily for each 28 day cycle.
LHRHa: Patients receive a LHRHa (monthly injection or three-month injection) for a maximum of 7 months before a prostatectomy is performed. Study doctor will decide what hormone therapy patient receives.
|
|---|---|---|
|
Proportion of Participants With Pathologic Stage Less Than or Equal to ypT2N0
|
11 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: For both groups, tumor samples collected at baseline and during surgery.The difference in the rate of positive surgical margins between the two groups will be descriptively summarized.
Outcome measures
| Measure |
Group B: Abiraterone + LHRHa + Prednisone
n=21 Participants
Patients receive abiraterone acetate (1,000 mg daily) plus prednisone (5mg once daily) and LHRHa. Patients receive a LHRHa (monthly injection or three-month injection) for a maximum of 7 months before a prostatectomy is performed. Study doctor will decide what hormone therapy patient receives.
Abiraterone Acetate: 1,000 mg by mouth daily for each 28 day cycle.
Prednisone: 5 mg by mouth once daily for each 28 day cycle.
LHRHa: Patients receive a LHRHa (monthly injection or three-month injection) for a maximum of 7 months before a prostatectomy is performed. Study doctor will decide what hormone therapy patient receives.
|
Group A: Abiraterone + Enzalutamide + LHRHa + Prednisone.
n=43 Participants
Patients receive abiraterone acetate (1,000 mg daily) plus prednisone (5mg once daily) in combination with enzalutamide (160 mg daily) and LHRHa. Patients receive a LHRHa (monthly injection or three-month injection) for a maximum of 7 months before a prostatectomy is performed. Study doctor will decide what hormone therapy patient receives.
Abiraterone Acetate: 1,000 mg by mouth daily for each 28 day cycle.
Prednisone: 5 mg by mouth once daily for each 28 day cycle.
Enzalutamide: 160 mg by mouth daily for each 28 day cycle.
LHRHa: Patients receive a LHRHa (monthly injection or three-month injection) for a maximum of 7 months before a prostatectomy is performed. Study doctor will decide what hormone therapy patient receives.
|
|---|---|---|
|
Proportion of Participants With Positive Surgical Margins
|
2 Participants
|
9 Participants
|
Adverse Events
Arm A: Abiraterone + Enzalutamide + LHRHa + Prednisone
Serious events: 4 serious events
Other events: 45 other events
Deaths: 0 deaths
Group B: Abiraterone + LHRHa + Prednisone
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A: Abiraterone + Enzalutamide + LHRHa + Prednisone
n=45 participants at risk
Patients receive abiraterone acetate (1,000 mg daily) plus prednisone (5mg once daily) in combination with enzalutamide (160 mg daily) and LHRHa. Patients receive a LHRHa (monthly injection or three-month injection) for a maximum of 7 months before a prostatectomy is performed. Study doctor will decide what hormone therapy patient receives.
Abiraterone Acetate: 1,000 mg by mouth daily for each 28 day cycle.
Prednisone: 5 mg by mouth once daily for each 28 day cycle.
Enzalutamide: 160 mg by mouth daily for each 28 day cycle.
LHRHa: Patients receive a LHRHa (monthly injection or three-month injection) for a maximum of 7 months before a prostatectomy is performed. Study doctor will decide what hormone therapy patient receives.
|
Group B: Abiraterone + LHRHa + Prednisone
n=23 participants at risk
Patients receive abiraterone acetate (1,000 mg daily) plus prednisone (5mg once daily) and LHRHa. Patients receive a LHRHa (monthly injection or three-month injection) for a maximum of 7 months before a prostatectomy is performed. Study doctor will decide what hormone therapy patient receives.
Abiraterone Acetate: 1,000 mg by mouth daily for each 28 day cycle.
Prednisone: 5 mg by mouth once daily for each 28 day cycle.
LHRHa: Patients receive a LHRHa (monthly injection or three-month injection) for a maximum of 7 months before a prostatectomy is performed. Study doctor will decide what hormone therapy patient receives.
|
|---|---|---|
|
Metabolism and nutrition disorders
pancreatitis
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Cardiac disorders
possible mini stroke
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Respiratory, thoracic and mediastinal disorders
PE
|
0.00%
0/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
4.3%
1/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Vascular disorders
abdominal pain
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
neoplasm
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Musculoskeletal and connective tissue disorders
hematoma
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
Other adverse events
| Measure |
Arm A: Abiraterone + Enzalutamide + LHRHa + Prednisone
n=45 participants at risk
Patients receive abiraterone acetate (1,000 mg daily) plus prednisone (5mg once daily) in combination with enzalutamide (160 mg daily) and LHRHa. Patients receive a LHRHa (monthly injection or three-month injection) for a maximum of 7 months before a prostatectomy is performed. Study doctor will decide what hormone therapy patient receives.
Abiraterone Acetate: 1,000 mg by mouth daily for each 28 day cycle.
Prednisone: 5 mg by mouth once daily for each 28 day cycle.
Enzalutamide: 160 mg by mouth daily for each 28 day cycle.
LHRHa: Patients receive a LHRHa (monthly injection or three-month injection) for a maximum of 7 months before a prostatectomy is performed. Study doctor will decide what hormone therapy patient receives.
|
Group B: Abiraterone + LHRHa + Prednisone
n=23 participants at risk
Patients receive abiraterone acetate (1,000 mg daily) plus prednisone (5mg once daily) and LHRHa. Patients receive a LHRHa (monthly injection or three-month injection) for a maximum of 7 months before a prostatectomy is performed. Study doctor will decide what hormone therapy patient receives.
Abiraterone Acetate: 1,000 mg by mouth daily for each 28 day cycle.
Prednisone: 5 mg by mouth once daily for each 28 day cycle.
LHRHa: Patients receive a LHRHa (monthly injection or three-month injection) for a maximum of 7 months before a prostatectomy is performed. Study doctor will decide what hormone therapy patient receives.
|
|---|---|---|
|
Vascular disorders
Abdominal pain
|
6.7%
3/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
13.0%
3/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Psychiatric disorders
Agitation
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
4.3%
1/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Hepatobiliary disorders
Alanine aminotransferase increased
|
82.2%
37/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
52.2%
12/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Investigations
Alkaline phosphatase increased
|
11.1%
5/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
4.3%
1/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Immune system disorders
Allergic reaction
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
4.3%
1/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Blood and lymphatic system disorders
Anemia
|
44.4%
20/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
39.1%
9/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Psychiatric disorders
Anxiety
|
6.7%
3/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
8.7%
2/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.8%
8/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
13.0%
3/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
4.4%
2/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Hepatobiliary disorders
Aspartate aminotransferase increased
|
53.3%
24/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
52.2%
12/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Cardiac disorders
Atrial fibrillation
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
4.3%
1/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Renal and urinary disorders
Bladder spasm
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Gastrointestinal disorders
Bloating
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
4.3%
1/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Hepatobiliary disorders
Blood bilirubin increased
|
22.2%
10/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
43.5%
10/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Eye disorders
Blurred vision
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
4.3%
1/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
4.3%
1/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Investigations
Cholesterol high
|
15.6%
7/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
21.7%
5/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Psychiatric disorders
Cognitive disturbance
|
8.9%
4/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Psychiatric disorders
Concentration impairment
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Gastrointestinal disorders
Constipation
|
8.9%
4/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
8.7%
2/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
13.0%
3/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Investigations
Creatinine increased
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
8.7%
2/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
4.3%
1/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Psychiatric disorders
Depressed level of consciousness
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Psychiatric disorders
Depression
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Gastrointestinal disorders
Diarrhea
|
11.1%
5/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
21.7%
5/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Nervous system disorders
Dizziness
|
20.0%
9/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Eye disorders
Dry eye
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
4.3%
1/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.4%
2/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
4.3%
1/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Nervous system disorders
Dysgeusia
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.1%
5/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
General disorders
Edema limbs
|
0.00%
0/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
8.7%
2/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
13.3%
6/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
13.0%
3/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Nervous system disorders
Extrapyramidal disorder
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
General disorders
Fatigue
|
75.6%
34/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
43.5%
10/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Gastrointestinal disorders
Flatulence
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
4.3%
1/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
General disorders
Gait disturbance
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
4.3%
1/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
8.7%
2/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Psychiatric disorders
Hallucinations
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Nervous system disorders
Headache
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Vascular disorders
Hematoma
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Renal and urinary disorders
Hematuria
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
13.0%
3/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Vascular disorders
Hot flashes
|
80.0%
36/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
69.6%
16/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
17.8%
8/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
8.7%
2/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
66.7%
30/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
65.2%
15/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.7%
3/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
8.7%
2/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
26.7%
12/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
34.8%
8/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Vascular disorders
Hypertension
|
31.1%
14/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
8.7%
2/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
22.2%
10/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
13.0%
3/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
4.3%
1/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
4.3%
1/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
26.7%
12/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
17.4%
4/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
26.7%
12/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
17.4%
4/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.4%
2/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
4.3%
1/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Endocrine disorders
Hypothyroidism
|
4.4%
2/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
4.3%
1/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Psychiatric disorders
Insomnia
|
11.1%
5/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
4.3%
1/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Investigations
Investigations - Other, specify
|
8.9%
4/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
General disorders
Irritability
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
4.3%
1/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Vascular disorders
Lymphedema
|
0.00%
0/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
4.3%
1/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
General disorders
Malaise
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Nervous system disorders
Memory impairment
|
17.8%
8/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
4.4%
2/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
4.4%
2/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.9%
4/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
4.3%
1/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Gastrointestinal disorders
Nausea
|
15.6%
7/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
8.7%
2/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
6.7%
3/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
General disorders
Non-cardiac chest pain
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
General disorders
Pain
|
15.6%
7/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
4.3%
1/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Nervous system disorders
Paresthesia
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Reproductive system and breast disorders
Perineal pain
|
4.4%
2/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
6.7%
3/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Infections and infestations
Prostate infection
|
0.00%
0/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
4.3%
1/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Renal and urinary disorders
Proteinuria
|
11.1%
5/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
17.4%
4/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Psychiatric disorders
Psychosis
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
4.3%
1/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Renal and urinary disorders
Renal calculi
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
4.3%
1/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
4.3%
1/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Psychiatric disorders
Restlessness
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
4.3%
1/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Reproductive system and breast disorders
Scrotal pain
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Infections and infestations
Sinusitis
|
4.4%
2/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
4.3%
1/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Reproductive system and breast disorders
Testicular pain
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Vascular disorders
Thromboembolic event
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Infections and infestations
Tooth infection
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Nervous system disorders
Transient ischemic attacks
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Injury, poisoning and procedural complications
Upper respiratory infection
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
4.3%
1/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Renal and urinary disorders
Urinary frequency
|
35.6%
16/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
30.4%
7/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Renal and urinary disorders
Urinary incontinence
|
22.2%
10/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
8.7%
2/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Renal and urinary disorders
Urinary tract infection
|
6.7%
3/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Renal and urinary disorders
Urinary tract pain
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Renal and urinary disorders
Urinary urgency
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
4.3%
1/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Gastrointestinal disorders
Vomiting
|
4.4%
2/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
4.3%
1/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Eye disorders
Watering eyes
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Metabolism and nutrition disorders
Weight loss
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
0.00%
0/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
|
Blood and lymphatic system disorders
White blood cell decreased
|
2.2%
1/45 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
4.3%
1/23 • From informed consent to 4 weeks after the patient has stopped treatment
Adverse events were collected and reported according to protocol requirements.
|
Additional Information
Christopher J. Logothetis M.D. / Genitourinary Medical Oncology
UT MD Anderson Cancer Center
Phone: 713-792-2830
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place