Trial Outcomes & Findings for SHIP (Selinexor in Hormone Insensitive Prostate Cancer) (NCT NCT02146833)
NCT ID: NCT02146833
Last Updated: 2023-01-26
Results Overview
CBR was defined as the point estimate of the percentage of participants who had complete response (CR), partial response (PR), or stable disease (SD) at 12 weeks as per the Response Evaluation Criteria in Solid Tumors (RECIST v.1.1; soft tissue lesions). CR: Disappearance of all target lesions. PR: At least a 30 percent (%) decrease in the sum of diameters of target lesions, taken as reference the baseline sum diameter. SD: steady state of disease; non-CR or non-PR or non-progressive disease.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
At 12 weeks
Results posted on
2023-01-26
Participant Flow
This study was conducted at single center in United States of America from May 2014 to 01 April 2016. Due to early termination of study, participants in Arm 2 and 3 were not enrolled.
A total of 20 participants were enrolled and treated in the study, of which 9 participants completed the study.
Participant milestones
| Measure |
Arm 1: Selinexor
Participants received a dose of 80 milligrams (mg) selinexor twice weekly orally on Days 1, 3, 8, 10, 15, 17, 22, and 24 of 28-day cycle until study discontinuation due to any reason.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Arm 1: Selinexor
Participants received a dose of 80 milligrams (mg) selinexor twice weekly orally on Days 1, 3, 8, 10, 15, 17, 22, and 24 of 28-day cycle until study discontinuation due to any reason.
|
|---|---|
|
Overall Study
Death
|
10
|
|
Overall Study
No longer consented to study treatment
|
1
|
Baseline Characteristics
SHIP (Selinexor in Hormone Insensitive Prostate Cancer)
Baseline characteristics by cohort
| Measure |
Arm 1: Selinexor
n=20 Participants
Participants received a dose of 80 mg selinexor twice weekly orally on Days 1, 3, 8, 10, 15, 17, 22, and 24 of 28-day cycle until study discontinuation due to any reason.
|
|---|---|
|
Age, Continuous
|
66.3 years
STANDARD_DEVIATION 9.62 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 12 weeksPopulation: Modified intent-to-treat (mITT) population:Participants who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment. Participants who received at least 1 dose of study drug, but discontinued treatment prior to first efficacy follow-up assessment due to death, toxicity, or disease progression were also included.
CBR was defined as the point estimate of the percentage of participants who had complete response (CR), partial response (PR), or stable disease (SD) at 12 weeks as per the Response Evaluation Criteria in Solid Tumors (RECIST v.1.1; soft tissue lesions). CR: Disappearance of all target lesions. PR: At least a 30 percent (%) decrease in the sum of diameters of target lesions, taken as reference the baseline sum diameter. SD: steady state of disease; non-CR or non-PR or non-progressive disease.
Outcome measures
| Measure |
Arm 1: Selinexor
n=20 Participants
Participants received a dose of 80 mg selinexor twice weekly orally on Days 1, 3, 8, 10, 15, 17, 22, and 24 of 28-day cycle until study discontinuation due to any reason.
|
|---|---|
|
Percentage of Participants With Overall Clinical Benefit Response (CBR)
|
25.0 Percentage of participants
|
SECONDARY outcome
Timeframe: From first dose of study treatment to time of disease progression or death, censored date (up to 23 months)Population: Due to early termination, data for this outcome measure was not collected and analyzed.
PFS was defined as the time from first dose of study treatment until the disease progression or death due to any cause per RECIST v.1.1 criteria. If date of progression or death occurred after more than 1 missed study visit, participants were censored at the time of last radiologic assessment prior to the missed visit. Participants without documented progression were also censored at the time of last radiologic assessment. Participants without any post baseline assessments were censored at date of start of study therapy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the date of first documented occurrence of response (CR or PR) until the date of documented progression or last disease assessment (up to 23 months)Population: mITT population: Participants who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment. In addition participants who received at least 1 dose of study drug, but discontinued treatment prior to first efficacy follow-up assessment due to death, toxicity, or disease progression were also included.
Best overall response rate was defined as the percentage of participants who achieved best response of CR, PR as assessed by the RECIST v1.1 criteria. CR was defined as disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taken as reference the baseline sum diameters.
Outcome measures
| Measure |
Arm 1: Selinexor
n=20 Participants
Participants received a dose of 80 mg selinexor twice weekly orally on Days 1, 3, 8, 10, 15, 17, 22, and 24 of 28-day cycle until study discontinuation due to any reason.
|
|---|---|
|
Percentage of Participants With Best Overall Response: RECIST v1.1 Criteria
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 (each cycle of 28 days) and End of Treatment (30 days after last dose of study treatment)Population: mITT population was used for this outcome measure. Here, "number analyzed" signifies those participants who were evaluable for each specified time point.
PSA marker was used for the assessment of disease progression and estimated the PSA level when compared to baseline.
Outcome measures
| Measure |
Arm 1: Selinexor
n=20 Participants
Participants received a dose of 80 mg selinexor twice weekly orally on Days 1, 3, 8, 10, 15, 17, 22, and 24 of 28-day cycle until study discontinuation due to any reason.
|
|---|---|
|
Absolute Values of Prostate Specific Antigen (PSA) Levels
Baseline
|
253.54 Microgram per liter (mcg/L)
Standard Deviation 380.796
|
|
Absolute Values of Prostate Specific Antigen (PSA) Levels
Cycle 2 Day 1
|
1606.42 Microgram per liter (mcg/L)
Standard Deviation 5889.324
|
|
Absolute Values of Prostate Specific Antigen (PSA) Levels
Cycle 3 Day 1
|
204.64 Microgram per liter (mcg/L)
Standard Deviation 316.759
|
|
Absolute Values of Prostate Specific Antigen (PSA) Levels
Cycle 4 Day 1
|
160.50 Microgram per liter (mcg/L)
Standard Deviation 242.479
|
|
Absolute Values of Prostate Specific Antigen (PSA) Levels
Cycle 5 Day 1
|
199.70 Microgram per liter (mcg/L)
Standard Deviation 294.026
|
|
Absolute Values of Prostate Specific Antigen (PSA) Levels
Cycle 6 Day 1
|
253.95 Microgram per liter (mcg/L)
Standard Deviation 388.829
|
|
Absolute Values of Prostate Specific Antigen (PSA) Levels
Cycle 7 Day 1
|
264.40 Microgram per liter (mcg/L)
Standard Deviation 456.858
|
|
Absolute Values of Prostate Specific Antigen (PSA) Levels
Cycle 8 Day 1
|
417.93 Microgram per liter (mcg/L)
Standard Deviation 697.107
|
|
Absolute Values of Prostate Specific Antigen (PSA) Levels
Cycle 9 Day 1
|
17.90 Microgram per liter (mcg/L)
Standard Deviation 24.607
|
|
Absolute Values of Prostate Specific Antigen (PSA) Levels
Cycle 10 Day 1
|
1.30 Microgram per liter (mcg/L)
Standard Deviation NA
Standard deviation was not calculated due to single participant.
|
|
Absolute Values of Prostate Specific Antigen (PSA) Levels
Cycle 11 Day 1
|
2.00 Microgram per liter (mcg/L)
Standard Deviation NA
Standard deviation was not calculated due to single participant.
|
|
Absolute Values of Prostate Specific Antigen (PSA) Levels
End of Treatment
|
1026.43 Microgram per liter (mcg/L)
Standard Deviation 2155.744
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 (each cycle of 28 days) and End of Treatment (30 days after last dose of study treatment)Population: mITT population was used for this outcome measure. Here, "number analyzed" signifies those participants who were evaluable for each specified time point.
PSA marker was used for the assessment of disease progression and estimated the PSA level when compared to baseline.
Outcome measures
| Measure |
Arm 1: Selinexor
n=20 Participants
Participants received a dose of 80 mg selinexor twice weekly orally on Days 1, 3, 8, 10, 15, 17, 22, and 24 of 28-day cycle until study discontinuation due to any reason.
|
|---|---|
|
Percent Change From Baseline in Prostate Specific Antigen Levels
Cycle 2 Day 1
|
210.74 percent change of PSA levels
Standard Deviation 699.683
|
|
Percent Change From Baseline in Prostate Specific Antigen Levels
Cycle 3 Day 1
|
80.31 percent change of PSA levels
Standard Deviation 90.723
|
|
Percent Change From Baseline in Prostate Specific Antigen Levels
Cycle 4 Day 1
|
30.51 percent change of PSA levels
Standard Deviation 60.739
|
|
Percent Change From Baseline in Prostate Specific Antigen Levels
Cycle 5 Day 1
|
187.86 percent change of PSA levels
Standard Deviation 321.389
|
|
Percent Change From Baseline in Prostate Specific Antigen Levels
Cycle 6 Day 1
|
281.05 percent change of PSA levels
Standard Deviation 457.228
|
|
Percent Change From Baseline in Prostate Specific Antigen Levels
Cycle 7 Day 1
|
327.46 percent change of PSA levels
Standard Deviation 572.347
|
|
Percent Change From Baseline in Prostate Specific Antigen Levels
Cycle 8 Day 1
|
92.37 percent change of PSA levels
Standard Deviation 167.366
|
|
Percent Change From Baseline in Prostate Specific Antigen Levels
Cycle 9 Day 1
|
1.43 percent change of PSA levels
Standard Deviation 84.514
|
|
Percent Change From Baseline in Prostate Specific Antigen Levels
Cycle 10 Day 1
|
8.33 percent change of PSA levels
Standard Deviation NA
Standard deviation was not calculated due to single participant.
|
|
Percent Change From Baseline in Prostate Specific Antigen Levels
Cycle 11 Day 1
|
66.67 percent change of PSA levels
Standard Deviation NA
Standard deviation was not calculated due to single participant.
|
|
Percent Change From Baseline in Prostate Specific Antigen Levels
End of Treatment
|
226.11 percent change of PSA levels
Standard Deviation 200.131
|
SECONDARY outcome
Timeframe: Baseline up to 12 weeksPopulation: Analysis population included all participants from mITT population who had PSA data at 12 weeks.
PSA response rate was defined as number of participants who achieved a ≥30% drop in PSA at 12 Weeks when compared to baseline.
Outcome measures
| Measure |
Arm 1: Selinexor
n=5 Participants
Participants received a dose of 80 mg selinexor twice weekly orally on Days 1, 3, 8, 10, 15, 17, 22, and 24 of 28-day cycle until study discontinuation due to any reason.
|
|---|---|
|
Prostate Specific Antigen Response Rate
|
1 Participants
|
SECONDARY outcome
Timeframe: From first dose of study treatment to death, censored date (up to 23 months)Population: Due to early termination, data for this outcome measure was not collected and analyzed.
OS was defined as the time from first dose of study treatment until death due to any cause. Participants who were still alive prior to the data cutoff for final efficacy analysis, or who dropout prior to study end, were censored at the day they were last known to be alive.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to 30 days after last dose of study treatment (up to 23 months)Population: Due to early termination, data for this outcome measure was not collected and analyzed.
Quality of life (QoL) was assessed by verbal rating of participant's pain according to present pain intensity index. Participants were asked to describe "how severe their pain was at very moment". Present pain intensity was assessed on 5-point visual analog scale ranging from 0 to 5, where 0-no pain, 1-mild pain, 2-discomforting pain, 3-distressing pain, 4-horrible pain, and 5-excruciating pain. The higher scores indicated higher pain.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From screening up to 23 monthsPopulation: Safety population: All participants who received any amount of study drug.
An adverse event (AE) was defined as the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition that occur after participant's signed informed consent obtained. A serious adverse event (SAE) was defined as any AE, occurring at any dose (including after the informed consent form was signed and prior to dosing) that and regardless of causality that: results in death, is life-threatening (participant was at immediate risk of death from event as it occurred), requires in-patient hospitalization (formal admission to a hospital for medical reasons) or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect. TEAE was defined as any AE with onset or worsening of a pre-existing condition on or after the first administration of study treatment through 28 days following last dose or any event considered drug-related by the investigator through the end of the study.
Outcome measures
| Measure |
Arm 1: Selinexor
n=20 Participants
Participants received a dose of 80 mg selinexor twice weekly orally on Days 1, 3, 8, 10, 15, 17, 22, and 24 of 28-day cycle until study discontinuation due to any reason.
|
|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) and Treatment Emergent Serious Adverse Events (TESAE)
At least one TEAE
|
20 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) and Treatment Emergent Serious Adverse Events (TESAE)
At least one TESAE
|
9 Participants
|
Adverse Events
Arm 1: Selinexor
Serious events: 9 serious events
Other events: 20 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
Arm 1: Selinexor
n=20 participants at risk
Participants received a dose of 80 mg selinexor twice weekly orally on Days 1, 3, 8, 10, 15, 17, 22, and 24 of 28-day cycle until study discontinuation due to any reason.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
10.0%
2/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.0%
1/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Infections and infestations
Influenza
|
5.0%
1/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Infections and infestations
Pneumonia Parainfluenzae Viral
|
5.0%
1/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.0%
1/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
1/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Nervous system disorders
Cerebrovascular Accident
|
10.0%
2/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Nervous system disorders
Hemiparesis
|
5.0%
1/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
General disorders
Pain
|
5.0%
1/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
General disorders
Pyrexia
|
5.0%
1/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.0%
1/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
Other adverse events
| Measure |
Arm 1: Selinexor
n=20 participants at risk
Participants received a dose of 80 mg selinexor twice weekly orally on Days 1, 3, 8, 10, 15, 17, 22, and 24 of 28-day cycle until study discontinuation due to any reason.
|
|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
80.0%
16/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
60.0%
12/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
55.0%
11/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
45.0%
9/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
25.0%
5/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
50.0%
10/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Metabolism and nutrition disorders
Abnormal Loss Of Weight
|
35.0%
7/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
35.0%
7/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
30.0%
6/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
25.0%
5/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Metabolism and nutrition disorders
Hypercreatininaemia
|
20.0%
4/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
20.0%
4/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
15.0%
3/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Metabolism and nutrition disorders
Hyperamylasaemia
|
10.0%
2/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
10.0%
2/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
10.0%
2/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
5.0%
1/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Metabolism and nutrition disorders
Hyperlipasaemia
|
5.0%
1/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
5.0%
1/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Nausea
|
55.0%
11/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Constipation
|
35.0%
7/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
5/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
4/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Anal Incontinence
|
10.0%
2/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Anal Paraesthesia
|
5.0%
1/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.0%
1/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
5.0%
1/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
General disorders
Fatigue
|
75.0%
15/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
General disorders
Oedema Peripheral
|
15.0%
3/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
General disorders
Gait Disturbance
|
5.0%
1/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
General disorders
Malaise
|
5.0%
1/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
40.0%
8/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Investigations
Aspartate Aminotransferase Increased
|
35.0%
7/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
30.0%
6/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Investigations
Alanine Aminotransferase Increased
|
25.0%
5/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Nervous system disorders
Dizziness
|
20.0%
4/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Nervous system disorders
Dysgeusia
|
10.0%
2/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Nervous system disorders
Hypersomnia
|
10.0%
2/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Nervous system disorders
Amnesia
|
5.0%
1/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Nervous system disorders
Ataxia
|
5.0%
1/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Nervous system disorders
Headache
|
5.0%
1/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
5.0%
1/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Nervous system disorders
Somnolence
|
5.0%
1/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.0%
3/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
15.0%
3/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
2/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
Hypercreatinaemia
|
10.0%
2/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
10.0%
2/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
5.0%
1/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
5.0%
1/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
1/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Psychiatric disorders
Insomnia
|
20.0%
4/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Psychiatric disorders
Confusional State
|
15.0%
3/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Psychiatric disorders
Agitation
|
5.0%
1/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Psychiatric disorders
Anxiety
|
5.0%
1/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Psychiatric disorders
Personality Change
|
5.0%
1/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Renal and urinary disorders
Proteinuria
|
35.0%
7/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Renal and urinary disorders
Haemoglobinuria
|
10.0%
2/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Renal and urinary disorders
Nocturia
|
10.0%
2/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Renal and urinary disorders
Urinary Retention
|
10.0%
2/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Renal and urinary disorders
Haematuria
|
5.0%
1/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Renal and urinary disorders
Pollakiuria
|
5.0%
1/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Renal and urinary disorders
Urinary Incontinence
|
5.0%
1/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
5/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
10.0%
2/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
1/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.0%
1/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
5.0%
1/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
5.0%
1/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
5.0%
1/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Vascular disorders
Hot Flush
|
10.0%
2/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Vascular disorders
Deep Vein Thrombosis
|
5.0%
1/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Vascular disorders
Hypertension
|
5.0%
1/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Vascular disorders
Hypotension
|
5.0%
1/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Vascular disorders
Venous Thrombosis
|
5.0%
1/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Eye disorders
Vision Blurred
|
15.0%
3/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Eye disorders
Cataract
|
5.0%
1/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Eye disorders
Dry Eye
|
5.0%
1/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Eye disorders
Photophobia
|
5.0%
1/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Infections and infestations
Sinusitis
|
10.0%
2/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Infections and infestations
Urinary Tract Infection
|
10.0%
2/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Infections and infestations
Bronchitis
|
5.0%
1/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
5.0%
1/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Ear and labyrinth disorders
Tinnitus
|
5.0%
1/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Endocrine disorders
Adrenal Insufficiency
|
5.0%
1/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
5.0%
1/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.0%
1/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
5.0%
1/20 • From screening up to 23 months
Safety population consisted of all participants who received any amount of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place