Trial Outcomes & Findings for Nivolumab in Patients With High-Risk Biochemically Recurrent Prostate Cancer (NCT NCT03637543)
NCT ID: NCT03637543
Last Updated: 2026-05-08
Results Overview
Proportion of patients with high-risk biochemically-recurrent (BCR) prostate cancer (PCa) who achieve disease control at 12 weeks, defined as a decline or stabilization in prostate-specific antigen (PSA) levels without symptomatic or radiographic progression, following 12 weeks of nivolumab treatment.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
12 weeks
Results posted on
2026-05-08
Participant Flow
Participant milestones
| Measure |
PD-L1 Negative
-Nivolumab will be given on day 1 of a 28-day cycle intravenously
Nivolumab: Nivolumab is an antibody inhibitor of the programmed death-1 (PD-1) pathway. By blocking PD-1, this medication may allow the immune system to recognize and fight cancer
|
PD-L1 Positive
-Nivolumab will be given on day 1 of a 28-day cycle intravenously
Nivolumab: Nivolumab is an antibody inhibitor of the programmed death-1 (PD-1) pathway. By blocking PD-1, this medication may allow the immune system to recognize and fight cancer
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
17
|
|
Overall Study
COMPLETED
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
9
|
15
|
Reasons for withdrawal
| Measure |
PD-L1 Negative
-Nivolumab will be given on day 1 of a 28-day cycle intravenously
Nivolumab: Nivolumab is an antibody inhibitor of the programmed death-1 (PD-1) pathway. By blocking PD-1, this medication may allow the immune system to recognize and fight cancer
|
PD-L1 Positive
-Nivolumab will be given on day 1 of a 28-day cycle intravenously
Nivolumab: Nivolumab is an antibody inhibitor of the programmed death-1 (PD-1) pathway. By blocking PD-1, this medication may allow the immune system to recognize and fight cancer
|
|---|---|---|
|
Overall Study
Radiographic progression
|
2
|
7
|
|
Overall Study
Clinical progression to metastatic progression
|
3
|
0
|
|
Overall Study
Physician Decision
|
2
|
1
|
|
Overall Study
Patient's decision
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
4
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Rising PSA & unacceptable toxicity
|
0
|
1
|
Baseline Characteristics
Nivolumab in Patients With High-Risk Biochemically Recurrent Prostate Cancer
Baseline characteristics by cohort
| Measure |
PD-L1 Negative
n=12 Participants
-Nivolumab will be given on day 1 of a 28-day cycle intravenously
Nivolumab: Nivolumab is an antibody inhibitor of the programmed death-1 (PD-1) pathway. By blocking PD-1, this medication may allow the immune system to recognize and fight cancer
|
PD-L1 Positive
n=17 Participants
-Nivolumab will be given on day 1 of a 28-day cycle intravenously
Nivolumab: Nivolumab is an antibody inhibitor of the programmed death-1 (PD-1) pathway. By blocking PD-1, this medication may allow the immune system to recognize and fight cancer
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72 years
n=41 Participants
|
66 years
n=40 Participants
|
68 years
n=81 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=81 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=41 Participants
|
17 Participants
n=40 Participants
|
29 Participants
n=81 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=81 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=81 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=81 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=81 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=41 Participants
|
16 Participants
n=40 Participants
|
26 Participants
n=81 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=81 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=41 Participants
|
1 Participants
n=40 Participants
|
3 Participants
n=81 Participants
|
|
Most recent pre-treatment PSA
|
3.5 ng/mL
n=41 Participants
|
2.4 ng/mL
n=40 Participants
|
2.6 ng/mL
n=81 Participants
|
|
PSA doubling time (study eligibility)
|
4.5 Months
n=41 Participants
|
4 Months
n=40 Participants
|
4 Months
n=81 Participants
|
|
ECOG performance status
0
|
11 Participants
n=41 Participants
|
16 Participants
n=40 Participants
|
27 Participants
n=81 Participants
|
|
ECOG performance status
1
|
1 Participants
n=41 Participants
|
1 Participants
n=40 Participants
|
2 Participants
n=81 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Patients who initiated nivolumab treatment
Proportion of patients with high-risk biochemically-recurrent (BCR) prostate cancer (PCa) who achieve disease control at 12 weeks, defined as a decline or stabilization in prostate-specific antigen (PSA) levels without symptomatic or radiographic progression, following 12 weeks of nivolumab treatment.
Outcome measures
| Measure |
PD-L1 Negative
n=12 Participants
-Nivolumab will be given on day 1 of a 28-day cycle intravenously
Nivolumab: Nivolumab is an antibody inhibitor of the programmed death-1 (PD-1) pathway. By blocking PD-1, this medication may allow the immune system to recognize and fight cancer
|
PD-L1 Positive
n=17 Participants
-Nivolumab will be given on day 1 of a 28-day cycle intravenously
Nivolumab: Nivolumab is an antibody inhibitor of the programmed death-1 (PD-1) pathway. By blocking PD-1, this medication may allow the immune system to recognize and fight cancer
|
|---|---|---|
|
Disease Control Rate at 12 Weeks
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Patients who initiated nivolumab treatment
Maximum percent change in prostate-specific antigen (PSA) from baseline observed at any time during nivolumab treatment, defined as the greatest decrease or increase in PSA relative to baseline. Participants are categorized based on maximum percent change in PSA as \<10% or ≥10% change.
Outcome measures
| Measure |
PD-L1 Negative
n=12 Participants
-Nivolumab will be given on day 1 of a 28-day cycle intravenously
Nivolumab: Nivolumab is an antibody inhibitor of the programmed death-1 (PD-1) pathway. By blocking PD-1, this medication may allow the immune system to recognize and fight cancer
|
PD-L1 Positive
n=17 Participants
-Nivolumab will be given on day 1 of a 28-day cycle intravenously
Nivolumab: Nivolumab is an antibody inhibitor of the programmed death-1 (PD-1) pathway. By blocking PD-1, this medication may allow the immune system to recognize and fight cancer
|
|---|---|---|
|
Number of Participants With Maximal Change in Prostate Specific Antigen (PSA) During Nivolumab Treatment
Maximal change greater than 10%
|
4 Participants
|
8 Participants
|
|
Number of Participants With Maximal Change in Prostate Specific Antigen (PSA) During Nivolumab Treatment
Maximal change less than 10%
|
8 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Patients who initiated nivolumab treatment. Patients with declining PSA values during treatment or with fewer than three PSA measurements were excluded.
Pre-treatment PSA doubling time (PSADT) was calculated using at least three PSA values obtained prior to treatment initiation. On-treatment PSADT required three consecutive PSA values ≥ 0.2 ng/mL, with the first and last measurements occurring within 12 months. End-of-treatment (EOT) PSADT was calculated using the three PSAs obtained immediately prior to EOT; it was not calculated for patients who discontinued treatment before cycle 4. PSADT was estimated using a linear regression model of the natural logarithm of PSA over time, following PCWG3 recommendations and the MSKCC calculator.
Outcome measures
| Measure |
PD-L1 Negative
n=11 Participants
-Nivolumab will be given on day 1 of a 28-day cycle intravenously
Nivolumab: Nivolumab is an antibody inhibitor of the programmed death-1 (PD-1) pathway. By blocking PD-1, this medication may allow the immune system to recognize and fight cancer
|
PD-L1 Positive
n=13 Participants
-Nivolumab will be given on day 1 of a 28-day cycle intravenously
Nivolumab: Nivolumab is an antibody inhibitor of the programmed death-1 (PD-1) pathway. By blocking PD-1, this medication may allow the immune system to recognize and fight cancer
|
|---|---|---|
|
Change in PSA Doubling Time (PSADT) Prior to End of Treatment Relative to Baseline
|
25 Months
Interval 10.0 to 46.0
|
27 Months
Interval 11.0 to 40.0
|
SECONDARY outcome
Timeframe: From initiation of nivolumab treatment until the date of first documented disease progression, assessed up to the end of the study.Population: Patients who initiated nivolumab treatment
Time to radiographic progression to metastatic disease was defined as the interval from treatment initiation to the first documentation of radiographic disease progression to metastatic disease per RECIST v1.1 criteria and Prostate Cancer Working Group (PCWG) guidelines, or censored at the date of last imaging assessment.
Outcome measures
| Measure |
PD-L1 Negative
n=12 Participants
-Nivolumab will be given on day 1 of a 28-day cycle intravenously
Nivolumab: Nivolumab is an antibody inhibitor of the programmed death-1 (PD-1) pathway. By blocking PD-1, this medication may allow the immune system to recognize and fight cancer
|
PD-L1 Positive
n=17 Participants
-Nivolumab will be given on day 1 of a 28-day cycle intravenously
Nivolumab: Nivolumab is an antibody inhibitor of the programmed death-1 (PD-1) pathway. By blocking PD-1, this medication may allow the immune system to recognize and fight cancer
|
|---|---|---|
|
Median Time to Radiographic Progression to Metastatic Disease
|
17 Months
Interval 7.0 to
Upper bound is not statistically reachable using the KM method
|
14 Months
Interval 7.0 to 26.0
|
SECONDARY outcome
Timeframe: From the first dose of nivolumab to initiation of ADT, assessed through end of study follow-up.Population: Patients who initiated nivolumab treatment
Time to initiation of ADT was defined as the interval from initiation of nivolumab to the start of systemic ADT. Participants who did not initiate ADT were censored at the date of last follow-up.
Outcome measures
| Measure |
PD-L1 Negative
n=12 Participants
-Nivolumab will be given on day 1 of a 28-day cycle intravenously
Nivolumab: Nivolumab is an antibody inhibitor of the programmed death-1 (PD-1) pathway. By blocking PD-1, this medication may allow the immune system to recognize and fight cancer
|
PD-L1 Positive
n=17 Participants
-Nivolumab will be given on day 1 of a 28-day cycle intravenously
Nivolumab: Nivolumab is an antibody inhibitor of the programmed death-1 (PD-1) pathway. By blocking PD-1, this medication may allow the immune system to recognize and fight cancer
|
|---|---|---|
|
Median Time to Initiation of Androgen Deprivation Therapy (ADT) After Nivolumab
|
17 Months
Interval 9.0 to
Upper bound is not statistically reachable using the KM method
|
19 Months
Interval 11.0 to 27.0
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Patients who initiated nivolumab treatment
The number of participants experiencing treatment-related adverse events of Grade 3 or higher that were assessed as definitely or probably related to study treatment, graded according to CTCAE v5.0.
Outcome measures
| Measure |
PD-L1 Negative
n=12 Participants
-Nivolumab will be given on day 1 of a 28-day cycle intravenously
Nivolumab: Nivolumab is an antibody inhibitor of the programmed death-1 (PD-1) pathway. By blocking PD-1, this medication may allow the immune system to recognize and fight cancer
|
PD-L1 Positive
n=17 Participants
-Nivolumab will be given on day 1 of a 28-day cycle intravenously
Nivolumab: Nivolumab is an antibody inhibitor of the programmed death-1 (PD-1) pathway. By blocking PD-1, this medication may allow the immune system to recognize and fight cancer
|
|---|---|---|
|
Number of Participants With Treatment Related Grade ≥3 Adverse Events
Definitely or probably related grade 3 or higher AE
|
0 Participants
|
3 Participants
|
|
Number of Participants With Treatment Related Grade ≥3 Adverse Events
Possibly related grade 3 or higher AE
|
0 Participants
|
2 Participants
|
Adverse Events
PD-L1 Negative
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
PD-L1 Positive
Serious events: 5 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PD-L1 Negative
n=12 participants at risk
-Nivolumab will be given on day 1 of a 28-day cycle intravenously
Nivolumab: Nivolumab is an antibody inhibitor of the programmed death-1 (PD-1) pathway. By blocking PD-1, this medication may allow the immune system to recognize and fight cancer
|
PD-L1 Positive
n=17 participants at risk
-Nivolumab will be given on day 1 of a 28-day cycle intravenously
Nivolumab: Nivolumab is an antibody inhibitor of the programmed death-1 (PD-1) pathway. By blocking PD-1, this medication may allow the immune system to recognize and fight cancer
|
|---|---|---|
|
Infections and infestations
Lung infection
|
0.00%
0/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
5.9%
1/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
11.8%
2/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
11.8%
2/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
5.9%
1/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
5.9%
1/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
5.9%
1/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
Other adverse events
| Measure |
PD-L1 Negative
n=12 participants at risk
-Nivolumab will be given on day 1 of a 28-day cycle intravenously
Nivolumab: Nivolumab is an antibody inhibitor of the programmed death-1 (PD-1) pathway. By blocking PD-1, this medication may allow the immune system to recognize and fight cancer
|
PD-L1 Positive
n=17 participants at risk
-Nivolumab will be given on day 1 of a 28-day cycle intravenously
Nivolumab: Nivolumab is an antibody inhibitor of the programmed death-1 (PD-1) pathway. By blocking PD-1, this medication may allow the immune system to recognize and fight cancer
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
5.9%
1/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
8.3%
1/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
0.00%
0/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Cardiac disorders
Atrial fibrillation
|
8.3%
1/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
0.00%
0/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Cardiac disorders
Heart failure
|
8.3%
1/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
0.00%
0/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
5.9%
1/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
0.00%
0/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
5.9%
1/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
11.8%
2/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Endocrine disorders
Hypothyroidism
|
16.7%
2/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
23.5%
4/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Eye disorders
Blurred vision
|
8.3%
1/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
0.00%
0/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Eye disorders
Eye disorders - Other, specify
|
8.3%
1/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
0.00%
0/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Eye disorders
Eye pain
|
0.00%
0/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
5.9%
1/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Eye disorders
Uveitis
|
8.3%
1/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
0.00%
0/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
2/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
11.8%
2/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Gastrointestinal disorders
Anal hemorrhage
|
0.00%
0/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
5.9%
1/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
5.9%
1/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
11.8%
2/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Gastrointestinal disorders
Diarrhea
|
8.3%
1/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
17.6%
3/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Gastrointestinal disorders
Dry mouth
|
25.0%
3/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
17.6%
3/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
8.3%
1/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
5.9%
1/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
8.3%
1/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
0.00%
0/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
5.9%
1/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
8.3%
1/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
0.00%
0/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
5.9%
1/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Gastrointestinal disorders
Toothache
|
8.3%
1/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
0.00%
0/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
5.9%
1/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
General disorders and administration site conditions
Edema limbs
|
0.00%
0/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
11.8%
2/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
General disorders and administration site conditions
Fatigue
|
33.3%
4/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
47.1%
8/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
General disorders and administration site conditions
General disorders and administration site conditions - Other, specify
|
8.3%
1/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
0.00%
0/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
General disorders and administration site conditions
Non-cardiac chest pain
|
8.3%
1/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
0.00%
0/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
General disorders and administration site conditions
Pain
|
33.3%
4/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
23.5%
4/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Infections and infestations
Eye infection
|
8.3%
1/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
0.00%
0/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
8.3%
1/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
17.6%
3/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Infections and infestations
Lung infection
|
8.3%
1/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
0.00%
0/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Infections and infestations
Penile infection
|
0.00%
0/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
5.9%
1/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
5.9%
1/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Infections and infestations
Upper respiratory infection
|
16.7%
2/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
0.00%
0/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Nervous system disorders
Neuralgia
|
8.3%
1/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
0.00%
0/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Injury, poisoning and procedural complications
Fall
|
16.7%
2/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
0.00%
0/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
17.6%
3/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
11.8%
2/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Investigations
Aspartate aminotransferase increased
|
8.3%
1/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
11.8%
2/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
11.8%
2/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Investigations
CPK increased
|
0.00%
0/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
5.9%
1/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Investigations
Creatinine increased
|
16.7%
2/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
17.6%
3/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
17.6%
3/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Investigations
Weight loss
|
16.7%
2/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
11.8%
2/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Metabolism and nutrition disorders
Anorexia
|
16.7%
2/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
0.00%
0/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
5.9%
1/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
5.9%
1/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.3%
1/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
0.00%
0/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
5.9%
1/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
23.5%
4/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
5.9%
1/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
1/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
5.9%
1/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
8.3%
1/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
0.00%
0/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
11.8%
2/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
2/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
23.5%
4/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
16.7%
2/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
5.9%
1/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Nervous system disorders
Dizziness
|
16.7%
2/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
17.6%
3/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Nervous system disorders
Dysgeusia
|
16.7%
2/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
0.00%
0/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Nervous system disorders
Headache
|
16.7%
2/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
29.4%
5/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Nervous system disorders
Paresthesia
|
8.3%
1/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
5.9%
1/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
5.9%
1/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Nervous system disorders
Seizure
|
8.3%
1/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
0.00%
0/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
5.9%
1/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
5.9%
1/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Renal and urinary disorders
Renal calculi
|
0.00%
0/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
5.9%
1/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Renal and urinary disorders
Urinary frequency
|
16.7%
2/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
5.9%
1/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Renal and urinary disorders
Urinary incontinence
|
16.7%
2/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
5.9%
1/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
5.9%
1/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
8.3%
1/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
0.00%
0/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
8.3%
1/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
5.9%
1/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
2/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
5.9%
1/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
2/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
11.8%
2/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.3%
1/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
0.00%
0/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.3%
1/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
0.00%
0/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
8.3%
1/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
0.00%
0/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
8.3%
1/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
0.00%
0/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
16.7%
2/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
0.00%
0/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
8.3%
1/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
0.00%
0/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
5.9%
1/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
0.00%
0/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
5.9%
1/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.3%
1/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
0.00%
0/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
8.3%
1/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
0.00%
0/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
8.3%
1/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
0.00%
0/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
3/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
35.3%
6/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
8.3%
1/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
17.6%
3/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
8.3%
1/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
35.3%
6/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
8.3%
1/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
11.8%
2/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
5.9%
1/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Vascular disorders
Hematoma
|
0.00%
0/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
5.9%
1/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Vascular disorders
Hot flashes
|
8.3%
1/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
0.00%
0/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
|
Vascular disorders
Hypertension
|
16.7%
2/12 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
29.4%
5/17 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 2 years.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60