Trial Outcomes & Findings for A Phase II Study of Androgen Deprivation Therapy With or Without Palbociclib in RB-Positive Metastatic Prostate Cancer (NCT NCT02059213)
NCT ID: NCT02059213
Last Updated: 2020-09-16
Results Overview
The primary analysis will be assessment of the proportion of patients who achieve a (Prostate-specific antigen) PSA \< 4ng/mL after seven months of protocol treatment in each arm.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
72 participants
Primary outcome timeframe
28 weeks
Results posted on
2020-09-16
Participant Flow
72 patients were enrolled to the trial. Seven patients did not have adequate tissue for testing retinoblastoma status. Two patients tested negative for retinoblastoma and one patient was found to have small cell metastasis and not adenocarcinoma. 62 patients were randomized.
Participant milestones
| Measure |
ADT Alone
Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).
|
ADT + Ibrance®
Ibrance® (125mg taken daily by mouth days 1-21 of a 28 day cycle) in addition to Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
42
|
|
Overall Study
Initiated Treatment
|
20
|
40
|
|
Overall Study
COMPLETED
|
20
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase II Study of Androgen Deprivation Therapy With or Without Palbociclib in RB-Positive Metastatic Prostate Cancer
Baseline characteristics by cohort
| Measure |
ADT Alone
n=20 Participants
Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).
|
ADT + Ibrance®
n=42 Participants
Ibrance® (125mg taken daily by mouth days 1-21 of a 28 day cycle) in addition to Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.5 years
n=5 Participants
|
67.5 years
n=7 Participants
|
67.5 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
|
20 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 weeksPopulation: 72 patients were enrolled to the trial. Seven patients did not have adequate tissue for testing retinoblastoma status. Two patients tested negative for retinoblastoma and one patient was found to have small cell metastasis and not adenocarcinoma. 62 patients were randomized. 60 randomized patients initiated therapy on trial.
The primary analysis will be assessment of the proportion of patients who achieve a (Prostate-specific antigen) PSA \< 4ng/mL after seven months of protocol treatment in each arm.
Outcome measures
| Measure |
ADT Alone
n=20 Participants
Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).
|
ADT + Ibrance®
n=40 Participants
Ibrance® (125mg taken daily by mouth days 1-21 of a 28 day cycle) in addition to Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).
|
|---|---|---|
|
Number of Patients Who Achieve a PSA ≤ 4ng/mL After Seven Months of Protocol Treatment in Each Arm
|
16 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: Up to 54 monthsGrade \>=3 adverse events that are possibly, probably or definitely related to study treatment, reported by number of participants affected in each arm
Outcome measures
| Measure |
ADT Alone
n=20 Participants
Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).
|
ADT + Ibrance®
n=40 Participants
Ibrance® (125mg taken daily by mouth days 1-21 of a 28 day cycle) in addition to Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).
|
|---|---|---|
|
Number of Participants With Grade >=3 Adverse Events That Are Possibly, Probably or Definitely Related to Study Treatment
|
0 participants
|
23 participants
|
SECONDARY outcome
Timeframe: Up to 54 monthsDuration of therapy will be reported to describe tolerability within each arm.
Outcome measures
| Measure |
ADT Alone
n=20 Participants
Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).
|
ADT + Ibrance®
n=40 Participants
Ibrance® (125mg taken daily by mouth days 1-21 of a 28 day cycle) in addition to Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).
|
|---|---|---|
|
Duration of Therapy
|
22.4 months
Standard Deviation 13.1
|
22.0 months
Standard Deviation 13.8
|
SECONDARY outcome
Timeframe: Up to 54 monthsOutcome measures
| Measure |
ADT Alone
n=20 Participants
Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).
|
ADT + Ibrance®
n=40 Participants
Ibrance® (125mg taken daily by mouth days 1-21 of a 28 day cycle) in addition to Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).
|
|---|---|---|
|
Proportion of Patients Who Achieve Undetectable PSA (<0.2ng/mL)
|
13 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Up to 54 months12-month biochemical progression-free survival rate will begin from treatment start until the event of biochemical (PSA) progression or death, whichever occurs first. Described by arm using Kaplan-Meier methods.
Outcome measures
| Measure |
ADT Alone
n=20 Participants
Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).
|
ADT + Ibrance®
n=40 Participants
Ibrance® (125mg taken daily by mouth days 1-21 of a 28 day cycle) in addition to Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).
|
|---|---|---|
|
Biochemical Progression-free Survival Rate
12-month
|
74.7 percentage of participants
Interval 49.4 to 88.6
|
76.5 percentage of participants
Interval 59.6 to 87.0
|
|
Biochemical Progression-free Survival Rate
26-month (time of last event in Arm 1)
|
45.8 percentage of participants
Interval 22.4 to 66.6
|
59.4 percentage of participants
Interval 41.7 to 73.3
|
|
Biochemical Progression-free Survival Rate
43-month (time of last event in Arm 2)
|
45.8 percentage of participants
Interval 22.4 to 66.6
|
33.9 percentage of participants
Interval 8.9 to 61.7
|
SECONDARY outcome
Timeframe: Up to 54 months12-month clinical progression-free survival rate will begin from treatment start until the event of biochemical (PSA) progression or death, whichever occurs first. Described by arm using Kaplan-Meier methods.
Outcome measures
| Measure |
ADT Alone
n=20 Participants
Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).
|
ADT + Ibrance®
n=40 Participants
Ibrance® (125mg taken daily by mouth days 1-21 of a 28 day cycle) in addition to Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).
|
|---|---|---|
|
Clinical Progression-free Survival Rate
12-month
|
77.7 percentage of participants
Interval 51.1 to 91.0
|
83.8 percentage of participants
Interval 67.4 to 92.4
|
|
Clinical Progression-free Survival Rate
22-month (time of last event in Arm 1)
|
64.8 percentage of participants
Interval 37.5 to 82.5
|
77.7 percentage of participants
Interval 60.2 to 88.2
|
|
Clinical Progression-free Survival Rate
32-month (time of last event in Arm 2)
|
64.8 percentage of participants
Interval 37.5 to 82.5
|
58.5 percentage of participants
Interval 33.9 to 76.6
|
SECONDARY outcome
Timeframe: Up to 54 monthsDose modifications will be reported to describe tolerability for arm 2 only (Ibrance®)
Outcome measures
| Measure |
ADT Alone
n=40 Participants
Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).
|
ADT + Ibrance®
Ibrance® (125mg taken daily by mouth days 1-21 of a 28 day cycle) in addition to Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).
|
|---|---|---|
|
Frequency of Dose Modification
No Dose Reduction (Palbociclib 125mg/day)
|
28 participants
|
—
|
|
Frequency of Dose Modification
1 Dose Reduction, to Palbociclib 100mg/day
|
5 participants
|
—
|
|
Frequency of Dose Modification
2 Dose Reductions, to Palbociclib 75mg/day
|
7 participants
|
—
|
SECONDARY outcome
Timeframe: Up to 54 monthsTreatment delays will be reported to describe tolerability within each arm.
Outcome measures
| Measure |
ADT Alone
n=20 Participants
Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).
|
ADT + Ibrance®
n=40 Participants
Ibrance® (125mg taken daily by mouth days 1-21 of a 28 day cycle) in addition to Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).
|
|---|---|---|
|
Frequency of Treatment Delay
No Treatment delay of Bicalutamide
|
19 participants
|
35 participants
|
|
Frequency of Treatment Delay
Treatment Delay of Bicalutamide
|
1 participants
|
5 participants
|
|
Frequency of Treatment Delay
No Treatment Delay of Palbociclib
|
0 participants
|
21 participants
|
|
Frequency of Treatment Delay
Treatment Delay of Palbociclib
|
0 participants
|
19 participants
|
Adverse Events
ADT Alone
Serious events: 5 serious events
Other events: 20 other events
Deaths: 0 deaths
ADT + Ibrance®
Serious events: 7 serious events
Other events: 40 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
ADT Alone
n=20 participants at risk
Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).
|
ADT + Ibrance®
n=40 participants at risk
Ibrance® (125mg taken daily by mouth days 1-21 of a 28 day cycle) in addition to Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).
|
|---|---|---|
|
Cardiac disorders
Aortic valve disease
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
0.00%
0/40 • Adverse events (AEs) were collected up to 44 months.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
General disorders
Fever
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
0.00%
0/40 • Adverse events (AEs) were collected up to 44 months.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
0.00%
0/40 • Adverse events (AEs) were collected up to 44 months.
|
|
Infections and infestations
Sepsis
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
0.00%
0/40 • Adverse events (AEs) were collected up to 44 months.
|
|
Infections and infestations
Urinary tract infection
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
0.00%
0/40 • Adverse events (AEs) were collected up to 44 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Nervous system disorders
Syncope
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Renal and urinary disorders
Acute kidney injury
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
0.00%
0/40 • Adverse events (AEs) were collected up to 44 months.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
0.00%
0/40 • Adverse events (AEs) were collected up to 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Vascular disorders
Hematoma
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
Other adverse events
| Measure |
ADT Alone
n=20 participants at risk
Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).
|
ADT + Ibrance®
n=40 participants at risk
Ibrance® (125mg taken daily by mouth days 1-21 of a 28 day cycle) in addition to Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
20.0%
4/20 • Number of events 5 • Adverse events (AEs) were collected up to 44 months.
|
32.5%
13/40 • Number of events 23 • Adverse events (AEs) were collected up to 44 months.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
7.5%
3/40 • Number of events 5 • Adverse events (AEs) were collected up to 44 months.
|
|
Blood and lymphatic system disorders
Bone marrow hypocellular
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Cardiac disorders
Aortic valve disease
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Cardiac disorders
Cardiac disorders - Other
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Cardiac disorders
Sinus bradycardia
|
10.0%
2/20 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
5.0%
2/40 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
5.0%
2/40 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
|
Ear and labyrinth disorders
Hearing impaired
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
10.0%
4/40 • Number of events 4 • Adverse events (AEs) were collected up to 44 months.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Ear and labyrinth disorders
Vertigo
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
5.0%
2/40 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
|
Ear and labyrinth disorders
Vestibular disorder
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
0.00%
0/40 • Adverse events (AEs) were collected up to 44 months.
|
|
Eye disorders
Blurred vision
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
7.5%
3/40 • Number of events 3 • Adverse events (AEs) were collected up to 44 months.
|
|
Eye disorders
Dry eye
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Eye disorders
Eye disorders - Other
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
7.5%
3/40 • Number of events 4 • Adverse events (AEs) were collected up to 44 months.
|
|
Eye disorders
Eye pain
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Eye disorders
Glaucoma
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
2/20 • Number of events 3 • Adverse events (AEs) were collected up to 44 months.
|
15.0%
6/40 • Number of events 6 • Adverse events (AEs) were collected up to 44 months.
|
|
Gastrointestinal disorders
Bloating
|
10.0%
2/20 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
0.00%
0/40 • Adverse events (AEs) were collected up to 44 months.
|
|
Gastrointestinal disorders
Constipation
|
10.0%
2/20 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
35.0%
14/40 • Number of events 18 • Adverse events (AEs) were collected up to 44 months.
|
|
Gastrointestinal disorders
Dental caries
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
12.5%
5/40 • Number of events 5 • Adverse events (AEs) were collected up to 44 months.
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
2/20 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
25.0%
10/40 • Number of events 12 • Adverse events (AEs) were collected up to 44 months.
|
|
Gastrointestinal disorders
Dry mouth
|
10.0%
2/20 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
7.5%
3/40 • Number of events 3 • Adverse events (AEs) were collected up to 44 months.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.0%
1/20 • Number of events 3 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
5.0%
2/40 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
5.0%
2/40 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
7.5%
3/40 • Number of events 3 • Adverse events (AEs) were collected up to 44 months.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
10.0%
4/40 • Number of events 4 • Adverse events (AEs) were collected up to 44 months.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
10.0%
2/20 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
20.0%
8/40 • Number of events 8 • Adverse events (AEs) were collected up to 44 months.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
4/20 • Number of events 6 • Adverse events (AEs) were collected up to 44 months.
|
22.5%
9/40 • Number of events 13 • Adverse events (AEs) were collected up to 44 months.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
0.00%
0/40 • Adverse events (AEs) were collected up to 44 months.
|
|
Gastrointestinal disorders
Stomach pain
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
0.00%
0/40 • Adverse events (AEs) were collected up to 44 months.
|
|
Gastrointestinal disorders
Toothache
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
5.0%
2/40 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
2/20 • Number of events 3 • Adverse events (AEs) were collected up to 44 months.
|
12.5%
5/40 • Number of events 17 • Adverse events (AEs) were collected up to 44 months.
|
|
General disorders
Chills
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
12.5%
5/40 • Number of events 5 • Adverse events (AEs) were collected up to 44 months.
|
|
General disorders
Edema limbs
|
35.0%
7/20 • Number of events 8 • Adverse events (AEs) were collected up to 44 months.
|
22.5%
9/40 • Number of events 11 • Adverse events (AEs) were collected up to 44 months.
|
|
General disorders
Fatigue
|
60.0%
12/20 • Number of events 16 • Adverse events (AEs) were collected up to 44 months.
|
57.5%
23/40 • Number of events 29 • Adverse events (AEs) were collected up to 44 months.
|
|
General disorders
Fever
|
5.0%
1/20 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
0.00%
0/40 • Adverse events (AEs) were collected up to 44 months.
|
|
General disorders
Flu like symptoms
|
15.0%
3/20 • Number of events 6 • Adverse events (AEs) were collected up to 44 months.
|
15.0%
6/40 • Number of events 10 • Adverse events (AEs) were collected up to 44 months.
|
|
General disorders
Gait disturbance
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
General disorders
General disorders and administration site conditions - Other
|
10.0%
2/20 • Number of events 3 • Adverse events (AEs) were collected up to 44 months.
|
20.0%
8/40 • Number of events 10 • Adverse events (AEs) were collected up to 44 months.
|
|
General disorders
Injection site reaction
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
7.5%
3/40 • Number of events 3 • Adverse events (AEs) were collected up to 44 months.
|
|
General disorders
Irritability
|
10.0%
2/20 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
General disorders
Non-cardiac chest pain
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
5.0%
2/40 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
|
General disorders
Pain
|
20.0%
4/20 • Number of events 7 • Adverse events (AEs) were collected up to 44 months.
|
30.0%
12/40 • Number of events 17 • Adverse events (AEs) were collected up to 44 months.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Infections and infestations
Infections and infestations - Other
|
10.0%
2/20 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
0.00%
0/40 • Adverse events (AEs) were collected up to 44 months.
|
|
Infections and infestations
Lip infection
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Infections and infestations
Nail infection
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
0.00%
0/40 • Adverse events (AEs) were collected up to 44 months.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Infections and infestations
Papulopustular rash
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Infections and infestations
Pharyngitis
|
10.0%
2/20 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Infections and infestations
Scrotal infection
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
0.00%
0/40 • Adverse events (AEs) were collected up to 44 months.
|
|
Infections and infestations
Sinusitis
|
10.0%
2/20 • Number of events 5 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Infections and infestations
Skin infection
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
5.0%
2/40 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
|
Infections and infestations
Upper respiratory infection
|
10.0%
2/20 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
22.5%
9/40 • Number of events 14 • Adverse events (AEs) were collected up to 44 months.
|
|
Infections and infestations
Urinary tract infection
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
10.0%
4/40 • Number of events 5 • Adverse events (AEs) were collected up to 44 months.
|
|
Injury, poisoning and procedural complications
Aortic injury
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
12.5%
5/40 • Number of events 5 • Adverse events (AEs) were collected up to 44 months.
|
|
Injury, poisoning and procedural complications
Burn
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Injury, poisoning and procedural complications
Fall
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
7.5%
3/40 • Number of events 3 • Adverse events (AEs) were collected up to 44 months.
|
|
Injury, poisoning and procedural complications
Fracture
|
5.0%
1/20 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
5.0%
2/40 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other
|
10.0%
2/20 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
0.00%
0/40 • Adverse events (AEs) were collected up to 44 months.
|
|
Investigations
Alanine aminotransferase increased
|
20.0%
4/20 • Number of events 5 • Adverse events (AEs) were collected up to 44 months.
|
12.5%
5/40 • Number of events 7 • Adverse events (AEs) were collected up to 44 months.
|
|
Investigations
Alkaline phosphatase increased
|
5.0%
1/20 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
10.0%
4/40 • Number of events 4 • Adverse events (AEs) were collected up to 44 months.
|
|
Investigations
Aspartate aminotransferase increased
|
15.0%
3/20 • Number of events 4 • Adverse events (AEs) were collected up to 44 months.
|
15.0%
6/40 • Number of events 9 • Adverse events (AEs) were collected up to 44 months.
|
|
Investigations
Blood bilirubin increased
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
|
Investigations
Cholesterol high
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Investigations
Creatinine increased
|
15.0%
3/20 • Number of events 5 • Adverse events (AEs) were collected up to 44 months.
|
7.5%
3/40 • Number of events 6 • Adverse events (AEs) were collected up to 44 months.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
5.0%
2/40 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
|
Investigations
Investigations - Other
|
10.0%
2/20 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
7.5%
3/40 • Number of events 4 • Adverse events (AEs) were collected up to 44 months.
|
|
Investigations
Lipase increased
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Investigations
Lymphocyte count decreased
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
15.0%
6/40 • Number of events 12 • Adverse events (AEs) were collected up to 44 months.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
62.5%
25/40 • Number of events 96 • Adverse events (AEs) were collected up to 44 months.
|
|
Investigations
Platelet count decreased
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
35.0%
14/40 • Number of events 29 • Adverse events (AEs) were collected up to 44 months.
|
|
Investigations
Weight gain
|
30.0%
6/20 • Number of events 12 • Adverse events (AEs) were collected up to 44 months.
|
17.5%
7/40 • Number of events 10 • Adverse events (AEs) were collected up to 44 months.
|
|
Investigations
Weight loss
|
10.0%
2/20 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
7.5%
3/40 • Number of events 6 • Adverse events (AEs) were collected up to 44 months.
|
|
Investigations
White blood cell decreased
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
47.5%
19/40 • Number of events 65 • Adverse events (AEs) were collected up to 44 months.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
20.0%
4/20 • Number of events 4 • Adverse events (AEs) were collected up to 44 months.
|
7.5%
3/40 • Number of events 3 • Adverse events (AEs) were collected up to 44 months.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
20.0%
4/20 • Number of events 13 • Adverse events (AEs) were collected up to 44 months.
|
37.5%
15/40 • Number of events 36 • Adverse events (AEs) were collected up to 44 months.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
10.0%
2/20 • Number of events 3 • Adverse events (AEs) were collected up to 44 months.
|
10.0%
4/40 • Number of events 4 • Adverse events (AEs) were collected up to 44 months.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
5.0%
1/20 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 4 • Adverse events (AEs) were collected up to 44 months.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
0.00%
0/40 • Adverse events (AEs) were collected up to 44 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
0.00%
0/40 • Adverse events (AEs) were collected up to 44 months.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.0%
1/20 • Number of events 3 • Adverse events (AEs) were collected up to 44 months.
|
0.00%
0/40 • Adverse events (AEs) were collected up to 44 months.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
7.5%
3/40 • Number of events 3 • Adverse events (AEs) were collected up to 44 months.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.0%
1/20 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
20.0%
4/20 • Number of events 5 • Adverse events (AEs) were collected up to 44 months.
|
17.5%
7/40 • Number of events 11 • Adverse events (AEs) were collected up to 44 months.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
5.0%
2/40 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
30.0%
6/20 • Number of events 8 • Adverse events (AEs) were collected up to 44 months.
|
12.5%
5/40 • Number of events 9 • Adverse events (AEs) were collected up to 44 months.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
15.0%
3/20 • Number of events 4 • Adverse events (AEs) were collected up to 44 months.
|
10.0%
4/40 • Number of events 6 • Adverse events (AEs) were collected up to 44 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
5/20 • Number of events 9 • Adverse events (AEs) were collected up to 44 months.
|
22.5%
9/40 • Number of events 14 • Adverse events (AEs) were collected up to 44 months.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
17.5%
7/40 • Number of events 8 • Adverse events (AEs) were collected up to 44 months.
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
0.00%
0/40 • Adverse events (AEs) were collected up to 44 months.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
7.5%
3/40 • Number of events 3 • Adverse events (AEs) were collected up to 44 months.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
12.5%
5/40 • Number of events 7 • Adverse events (AEs) were collected up to 44 months.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
0.00%
0/40 • Adverse events (AEs) were collected up to 44 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
15.0%
3/20 • Number of events 6 • Adverse events (AEs) were collected up to 44 months.
|
20.0%
8/40 • Number of events 10 • Adverse events (AEs) were collected up to 44 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
20.0%
8/40 • Number of events 12 • Adverse events (AEs) were collected up to 44 months.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.0%
1/20 • Number of events 3 • Adverse events (AEs) were collected up to 44 months.
|
7.5%
3/40 • Number of events 3 • Adverse events (AEs) were collected up to 44 months.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
35.0%
7/20 • Number of events 7 • Adverse events (AEs) were collected up to 44 months.
|
10.0%
4/40 • Number of events 4 • Adverse events (AEs) were collected up to 44 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
|
5.0%
1/20 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Nervous system disorders
Akathisia
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Nervous system disorders
Concentration impairment
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
5.0%
2/40 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
|
Nervous system disorders
Dizziness
|
20.0%
4/20 • Number of events 5 • Adverse events (AEs) were collected up to 44 months.
|
22.5%
9/40 • Number of events 13 • Adverse events (AEs) were collected up to 44 months.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
7.5%
3/40 • Number of events 5 • Adverse events (AEs) were collected up to 44 months.
|
|
Nervous system disorders
Headache
|
10.0%
2/20 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
15.0%
6/40 • Number of events 8 • Adverse events (AEs) were collected up to 44 months.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Nervous system disorders
Memory impairment
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
5.0%
2/40 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
|
Nervous system disorders
Nervous system disorders - Other
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Nervous system disorders
Paresthesia
|
15.0%
3/20 • Number of events 5 • Adverse events (AEs) were collected up to 44 months.
|
7.5%
3/40 • Number of events 4 • Adverse events (AEs) were collected up to 44 months.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
15.0%
6/40 • Number of events 7 • Adverse events (AEs) were collected up to 44 months.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Nervous system disorders
Radiculitis
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Nervous system disorders
Syncope
|
10.0%
2/20 • Number of events 3 • Adverse events (AEs) were collected up to 44 months.
|
0.00%
0/40 • Adverse events (AEs) were collected up to 44 months.
|
|
Nervous system disorders
Tremor
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
5.0%
2/40 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
|
Psychiatric disorders
Anxiety
|
15.0%
3/20 • Number of events 3 • Adverse events (AEs) were collected up to 44 months.
|
7.5%
3/40 • Number of events 4 • Adverse events (AEs) were collected up to 44 months.
|
|
Psychiatric disorders
Depression
|
15.0%
3/20 • Number of events 3 • Adverse events (AEs) were collected up to 44 months.
|
20.0%
8/40 • Number of events 10 • Adverse events (AEs) were collected up to 44 months.
|
|
Psychiatric disorders
Insomnia
|
20.0%
4/20 • Number of events 4 • Adverse events (AEs) were collected up to 44 months.
|
22.5%
9/40 • Number of events 9 • Adverse events (AEs) were collected up to 44 months.
|
|
Psychiatric disorders
Libido decreased
|
10.0%
2/20 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
0.00%
0/40 • Adverse events (AEs) were collected up to 44 months.
|
|
Psychiatric disorders
Psychiatric disorders - Other
|
15.0%
3/20 • Number of events 4 • Adverse events (AEs) were collected up to 44 months.
|
5.0%
2/40 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Renal and urinary disorders
Cystitis noninfective
|
10.0%
2/20 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
5.0%
2/40 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
|
Renal and urinary disorders
Hematuria
|
15.0%
3/20 • Number of events 3 • Adverse events (AEs) were collected up to 44 months.
|
7.5%
3/40 • Number of events 4 • Adverse events (AEs) were collected up to 44 months.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
5.0%
2/40 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
|
Renal and urinary disorders
Renal calculi
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Renal and urinary disorders
Urinary frequency
|
15.0%
3/20 • Number of events 3 • Adverse events (AEs) were collected up to 44 months.
|
17.5%
7/40 • Number of events 7 • Adverse events (AEs) were collected up to 44 months.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
5.0%
2/40 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
|
Renal and urinary disorders
Urinary retention
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
0.00%
0/40 • Adverse events (AEs) were collected up to 44 months.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Renal and urinary disorders
Urinary tract pain
|
10.0%
2/20 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
5.0%
2/40 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
5.0%
2/40 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
|
Reproductive system and breast disorders
Breast pain
|
5.0%
1/20 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
10.0%
2/20 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
7.5%
3/40 • Number of events 3 • Adverse events (AEs) were collected up to 44 months.
|
|
Reproductive system and breast disorders
Gynecomastia
|
20.0%
4/20 • Number of events 4 • Adverse events (AEs) were collected up to 44 months.
|
20.0%
8/40 • Number of events 8 • Adverse events (AEs) were collected up to 44 months.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
5.0%
2/40 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
5.0%
2/40 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
|
Reproductive system and breast disorders
Testicular pain
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
7.5%
3/40 • Number of events 3 • Adverse events (AEs) were collected up to 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
10.0%
2/20 • Number of events 5 • Adverse events (AEs) were collected up to 44 months.
|
15.0%
6/40 • Number of events 6 • Adverse events (AEs) were collected up to 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
4/20 • Number of events 5 • Adverse events (AEs) were collected up to 44 months.
|
40.0%
16/40 • Number of events 19 • Adverse events (AEs) were collected up to 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
2/20 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
22.5%
9/40 • Number of events 9 • Adverse events (AEs) were collected up to 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
10.0%
4/40 • Number of events 5 • Adverse events (AEs) were collected up to 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
15.0%
6/40 • Number of events 6 • Adverse events (AEs) were collected up to 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
7.5%
3/40 • Number of events 7 • Adverse events (AEs) were collected up to 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
7.5%
3/40 • Number of events 4 • Adverse events (AEs) were collected up to 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
0.00%
0/40 • Adverse events (AEs) were collected up to 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
5.0%
2/40 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
10.0%
2/20 • Number of events 3 • Adverse events (AEs) were collected up to 44 months.
|
12.5%
5/40 • Number of events 7 • Adverse events (AEs) were collected up to 44 months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
20.0%
4/20 • Number of events 4 • Adverse events (AEs) were collected up to 44 months.
|
25.0%
10/40 • Number of events 10 • Adverse events (AEs) were collected up to 44 months.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
12.5%
5/40 • Number of events 5 • Adverse events (AEs) were collected up to 44 months.
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
5.0%
2/40 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
5.0%
2/40 • Number of events 3 • Adverse events (AEs) were collected up to 44 months.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
0.00%
0/40 • Adverse events (AEs) were collected up to 44 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
5.0%
2/40 • Number of events 5 • Adverse events (AEs) were collected up to 44 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
5.0%
2/40 • Number of events 3 • Adverse events (AEs) were collected up to 44 months.
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
20.0%
4/20 • Number of events 6 • Adverse events (AEs) were collected up to 44 months.
|
25.0%
10/40 • Number of events 13 • Adverse events (AEs) were collected up to 44 months.
|
|
Skin and subcutaneous tissue disorders
Skin atrophy
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Vascular disorders
Flushing
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
|
Vascular disorders
Hot flashes
|
80.0%
16/20 • Number of events 19 • Adverse events (AEs) were collected up to 44 months.
|
77.5%
31/40 • Number of events 36 • Adverse events (AEs) were collected up to 44 months.
|
|
Vascular disorders
Hypertension
|
10.0%
2/20 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
20.0%
8/40 • Number of events 17 • Adverse events (AEs) were collected up to 44 months.
|
|
Vascular disorders
Hypotension
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
0.00%
0/40 • Adverse events (AEs) were collected up to 44 months.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/20 • Adverse events (AEs) were collected up to 44 months.
|
5.0%
2/40 • Number of events 2 • Adverse events (AEs) were collected up to 44 months.
|
|
Vascular disorders
Vascular disorders - Other
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected up to 44 months.
|
Additional Information
Phillip Palmbos, M.D., Ph.D.
University of Michigan Rogel Cancer Center
Phone: 734-936-3591
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place