Trial Outcomes & Findings for Phase 2 Study of Sym004 for Adult Patients With Recurrent Glioblastoma (NCT NCT02540161)
NCT ID: NCT02540161
Last Updated: 2020-08-05
Results Overview
Within each cohort, the percentage of participants alive and progression-free at 6 months after the start of Sym004 treatment will be determined. PFS6 will be calculated from the date study treatment started until the date of progression or death, or the date of last follow-up if participants are alive without progression. Kaplan-Meier methods will be used to estimate survival.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
43 participants
Primary outcome timeframe
6 months
Results posted on
2020-08-05
Participant Flow
43 patients signed consent and were considered enrolled, however 3 patients withdrew consent prior to treatment and 1 patient was withdrawn by PI prior to treatment.
Participant milestones
| Measure |
Non-bevacizumab Failures - 18 mg/kg
Non-bevacizumab failure (either no prior bevacizumab or bevacizumab stable/responder, which is defined as stable for at least 6 months from prior treatment with bevacizumab without experiencing a bevacizumab adverse event of special interest (AESI) while on a bevacizumab-containing regimen) will receive Sym004 intravenously every two weeks.
Sym004 - 18 mg/kg: Sym004 was dosed at 18 mg/kg intravenously every two weeks.
|
Bevacizumab Failures - 18 mg/kg
Prior progression on a bevacizumab-containing regimen (defined as having progressed/grown through bevacizumab by RANO criteria within 2 months of prior bevacizumab treatment) will receive Sym004 intravenously every two weeks.
Sym004 - 18 mg/kg: Sym004 was dosed at 18 mg/kg intravenously every two weeks.
|
Non-bevacizumab Failures - 24 mg/kg
Non-bevacizumab failure (either no prior bevacizumab or bevacizumab stable/responder, which is defined as stable for at least 6 months from prior treatment with bevacizumab without experiencing a bevacizumab adverse event of special interest (AESI) while on a bevacizumab-containing regimen) will receive Sym004 intravenously every two weeks.
Sym004 - 24 mg/kg: Beginning in August 2017, the dose was increased to 24 mg/kg intravenously every two weeks.
|
Bevacizumab Failures - 24 mg/kg
Prior progression on a bevacizumab-containing regimen (defined as having progressed/grown through bevacizumab by RANO criteria within 2 months of prior bevacizumab treatment) will receive Sym004 intravenously every two weeks.
Sym004 - 24 mg/kg: Beginning in August 2017, the dose was increased to 24 mg/kg intravenously every two weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
7
|
5
|
7
|
|
Overall Study
COMPLETED
|
20
|
7
|
5
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 2 Study of Sym004 for Adult Patients With Recurrent Glioblastoma
Baseline characteristics by cohort
| Measure |
Non-bevacizumab Failures - 18 mg/kg
n=20 Participants
Non-bevacizumab failure (either no prior bevacizumab or bevacizumab stable/responder, which is defined as stable for at least 6 months from prior treatment with bevacizumab without experiencing a bevacizumab adverse event of special interest (AESI) while on a bevacizumab-containing regimen) will receive Sym004 intravenously every two weeks.
Sym004 - 18 mg/kg: Sym004 was dosed at 18 mg/kg intravenously every two weeks.
|
Bevacizumab Failures - 18 mg/kg
n=7 Participants
Prior progression on a bevacizumab-containing regimen (defined as having progressed/grown through bevacizumab by RANO criteria within 2 months of prior bevacizumab treatment) will receive Sym004 intravenously every two weeks.
Sym004 - 18 mg/kg: Sym004 was dosed at 18 mg/kg intravenously every two weeks.
|
Non-bevacizumab Failures - 24 mg/kg
n=5 Participants
Non-bevacizumab failure (either no prior bevacizumab or bevacizumab stable/responder, which is defined as stable for at least 6 months from prior treatment with bevacizumab without experiencing a bevacizumab adverse event of special interest (AESI) while on a bevacizumab-containing regimen) will receive Sym004 intravenously every two weeks.
Sym004 - 24 mg/kg: Beginning in August 2017, the dose was increased to 24 mg/kg intravenously every two weeks.
|
Bevacizumab Failures - 24 mg/kg
n=7 Participants
Prior progression on a bevacizumab-containing regimen (defined as having progressed/grown through bevacizumab by RANO criteria within 2 months of prior bevacizumab treatment) will receive Sym004 intravenously every two weeks.
Sym004 - 24 mg/kg: Beginning in August 2017, the dose was increased to 24 mg/kg intravenously every two weeks.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
58.5 years
n=99 Participants
|
53 years
n=107 Participants
|
61 years
n=206 Participants
|
56 years
n=7 Participants
|
57.25 years
n=31 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
15 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
24 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
38 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
37 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=99 Participants
|
7 participants
n=107 Participants
|
5 participants
n=206 Participants
|
7 participants
n=7 Participants
|
39 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 6 monthsWithin each cohort, the percentage of participants alive and progression-free at 6 months after the start of Sym004 treatment will be determined. PFS6 will be calculated from the date study treatment started until the date of progression or death, or the date of last follow-up if participants are alive without progression. Kaplan-Meier methods will be used to estimate survival.
Outcome measures
| Measure |
Non-bevacizumab Failures - 18 mg/kg
n=20 Participants
Non-bevacizumab failure (either no prior bevacizumab or bevacizumab stable/responder, which is defined as stable for at least 6 months from prior treatment with bevacizumab without experiencing a bevacizumab adverse event of special interest (AESI) while on a bevacizumab-containing regimen) will receive Sym004 intravenously every two weeks.
Sym004 - 18 mg/kg: Sym004 was dosed at 18 mg/kg intravenously every two weeks.
|
Bevacizumab Failures - 18 mg/kg
n=7 Participants
Prior progression on a bevacizumab-containing regimen (defined as having progressed/grown through bevacizumab by RANO criteria within 2 months of prior bevacizumab treatment) will receive Sym004 intravenously every two weeks.
Sym004 - 18 mg/kg: Sym004 was dosed at 18 mg/kg intravenously every two weeks.
|
Non-bevacizumab Failures - 24 mg/kg
n=5 Participants
Non-bevacizumab failure (either no prior bevacizumab or bevacizumab stable/responder, which is defined as stable for at least 6 months from prior treatment with bevacizumab without experiencing a bevacizumab adverse event of special interest (AESI) while on a bevacizumab-containing regimen) will receive Sym004 intravenously every two weeks.
Sym004 - 24 mg/kg: Beginning in August 2017, the dose was increased to 24 mg/kg intravenously every two weeks.
|
Bevacizumab Failures - 24 mg/kg
n=7 Participants
Prior progression on a bevacizumab-containing regimen (defined as having progressed/grown through bevacizumab by RANO criteria within 2 months of prior bevacizumab treatment) will receive Sym004 intravenously every two weeks.
Sym004 - 24 mg/kg: Beginning in August 2017, the dose was increased to 24 mg/kg intravenously every two weeks.
|
|---|---|---|---|---|
|
Six-month Progression-free Survival (PFS6)
|
14.3 percentage of participants
Interval 0.7 to 46.5
|
5 percentage of participants
Interval 0.3 to 20.5
|
14.3 percentage of participants
Interval 0.7 to 46.5
|
40 percentage of participants
Interval 5.2 to 75.3
|
SECONDARY outcome
Timeframe: 2 yearsWithin each cohort, the percentage of participants who experience grade 3, 4 or 5 adverse events that are possibly, probably or definitely related to study treatment will be calculated.
Outcome measures
| Measure |
Non-bevacizumab Failures - 18 mg/kg
n=20 Participants
Non-bevacizumab failure (either no prior bevacizumab or bevacizumab stable/responder, which is defined as stable for at least 6 months from prior treatment with bevacizumab without experiencing a bevacizumab adverse event of special interest (AESI) while on a bevacizumab-containing regimen) will receive Sym004 intravenously every two weeks.
Sym004 - 18 mg/kg: Sym004 was dosed at 18 mg/kg intravenously every two weeks.
|
Bevacizumab Failures - 18 mg/kg
n=7 Participants
Prior progression on a bevacizumab-containing regimen (defined as having progressed/grown through bevacizumab by RANO criteria within 2 months of prior bevacizumab treatment) will receive Sym004 intravenously every two weeks.
Sym004 - 18 mg/kg: Sym004 was dosed at 18 mg/kg intravenously every two weeks.
|
Non-bevacizumab Failures - 24 mg/kg
n=5 Participants
Non-bevacizumab failure (either no prior bevacizumab or bevacizumab stable/responder, which is defined as stable for at least 6 months from prior treatment with bevacizumab without experiencing a bevacizumab adverse event of special interest (AESI) while on a bevacizumab-containing regimen) will receive Sym004 intravenously every two weeks.
Sym004 - 24 mg/kg: Beginning in August 2017, the dose was increased to 24 mg/kg intravenously every two weeks.
|
Bevacizumab Failures - 24 mg/kg
n=7 Participants
Prior progression on a bevacizumab-containing regimen (defined as having progressed/grown through bevacizumab by RANO criteria within 2 months of prior bevacizumab treatment) will receive Sym004 intravenously every two weeks.
Sym004 - 24 mg/kg: Beginning in August 2017, the dose was increased to 24 mg/kg intravenously every two weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Who Experience Grade 3, 4 or 5 Adverse Events
|
15 percentage of participants
|
42.86 percentage of participants
|
40 percentage of participants
|
14.29 percentage of participants
|
SECONDARY outcome
Timeframe: 2 yearsWithin each cohort, the percentage of participants with a complete or partial response as determined by modified Response Assessment in Neuro-Oncology (RANO) criteria will be determined. Complete Response (CR) is defined as complete disappearance on MR/CT of all enhancing tumor and mass effect, off all corticosteroids (or receiving only adrenal replacement doses) and accompanied by a stable or improving neurologic examination. Partial Response (PR) is defined as greater than or equal to 50% reduction in tumor size on MR/CT by bi-dimensional measurement, on a stable or decreasing dose of corticosteroids and accompanied by a stable or improving neurologic examination. Tumor assessments are done at baseline and the end of every second cycle (every 8 weeks) thereafter.
Outcome measures
| Measure |
Non-bevacizumab Failures - 18 mg/kg
n=20 Participants
Non-bevacizumab failure (either no prior bevacizumab or bevacizumab stable/responder, which is defined as stable for at least 6 months from prior treatment with bevacizumab without experiencing a bevacizumab adverse event of special interest (AESI) while on a bevacizumab-containing regimen) will receive Sym004 intravenously every two weeks.
Sym004 - 18 mg/kg: Sym004 was dosed at 18 mg/kg intravenously every two weeks.
|
Bevacizumab Failures - 18 mg/kg
n=7 Participants
Prior progression on a bevacizumab-containing regimen (defined as having progressed/grown through bevacizumab by RANO criteria within 2 months of prior bevacizumab treatment) will receive Sym004 intravenously every two weeks.
Sym004 - 18 mg/kg: Sym004 was dosed at 18 mg/kg intravenously every two weeks.
|
Non-bevacizumab Failures - 24 mg/kg
n=5 Participants
Non-bevacizumab failure (either no prior bevacizumab or bevacizumab stable/responder, which is defined as stable for at least 6 months from prior treatment with bevacizumab without experiencing a bevacizumab adverse event of special interest (AESI) while on a bevacizumab-containing regimen) will receive Sym004 intravenously every two weeks.
Sym004 - 24 mg/kg: Beginning in August 2017, the dose was increased to 24 mg/kg intravenously every two weeks.
|
Bevacizumab Failures - 24 mg/kg
n=7 Participants
Prior progression on a bevacizumab-containing regimen (defined as having progressed/grown through bevacizumab by RANO criteria within 2 months of prior bevacizumab treatment) will receive Sym004 intravenously every two weeks.
Sym004 - 24 mg/kg: Beginning in August 2017, the dose was increased to 24 mg/kg intravenously every two weeks.
|
|---|---|---|---|---|
|
Radiographic Response
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 2 yearsMedian PFS will be estimated within each cohort. Progression-free survival is defined as the time in months from the start of protocol treatment until the date of progression or death if death occurred before progression. If the participant is alive and progression-free, PFS will be censored at the date of last follow-up. Kaplan-Meier methods will be used to estimate progression-free survival.
Outcome measures
| Measure |
Non-bevacizumab Failures - 18 mg/kg
n=20 Participants
Non-bevacizumab failure (either no prior bevacizumab or bevacizumab stable/responder, which is defined as stable for at least 6 months from prior treatment with bevacizumab without experiencing a bevacizumab adverse event of special interest (AESI) while on a bevacizumab-containing regimen) will receive Sym004 intravenously every two weeks.
Sym004 - 18 mg/kg: Sym004 was dosed at 18 mg/kg intravenously every two weeks.
|
Bevacizumab Failures - 18 mg/kg
n=7 Participants
Prior progression on a bevacizumab-containing regimen (defined as having progressed/grown through bevacizumab by RANO criteria within 2 months of prior bevacizumab treatment) will receive Sym004 intravenously every two weeks.
Sym004 - 18 mg/kg: Sym004 was dosed at 18 mg/kg intravenously every two weeks.
|
Non-bevacizumab Failures - 24 mg/kg
n=5 Participants
Non-bevacizumab failure (either no prior bevacizumab or bevacizumab stable/responder, which is defined as stable for at least 6 months from prior treatment with bevacizumab without experiencing a bevacizumab adverse event of special interest (AESI) while on a bevacizumab-containing regimen) will receive Sym004 intravenously every two weeks.
Sym004 - 24 mg/kg: Beginning in August 2017, the dose was increased to 24 mg/kg intravenously every two weeks.
|
Bevacizumab Failures - 24 mg/kg
n=7 Participants
Prior progression on a bevacizumab-containing regimen (defined as having progressed/grown through bevacizumab by RANO criteria within 2 months of prior bevacizumab treatment) will receive Sym004 intravenously every two weeks.
Sym004 - 24 mg/kg: Beginning in August 2017, the dose was increased to 24 mg/kg intravenously every two weeks.
|
|---|---|---|---|---|
|
Median Progression-free Survival (PFS)
|
1.81 months
Interval 1.35 to 2.43
|
3.91 months
Interval 1.51 to 5.79
|
3.55 months
Interval 0.65 to 11.27
|
2.00 months
Interval 0.85 to 2.2
|
SECONDARY outcome
Timeframe: 2 yearsMedian OS will be estimated within each cohort. Overall survival is defined as the time in months from the start of protocol treatment until the date of death, or the date of last follow-up if alive. Kaplan-Meier methods will be used to estimate overall survival.
Outcome measures
| Measure |
Non-bevacizumab Failures - 18 mg/kg
n=20 Participants
Non-bevacizumab failure (either no prior bevacizumab or bevacizumab stable/responder, which is defined as stable for at least 6 months from prior treatment with bevacizumab without experiencing a bevacizumab adverse event of special interest (AESI) while on a bevacizumab-containing regimen) will receive Sym004 intravenously every two weeks.
Sym004 - 18 mg/kg: Sym004 was dosed at 18 mg/kg intravenously every two weeks.
|
Bevacizumab Failures - 18 mg/kg
n=7 Participants
Prior progression on a bevacizumab-containing regimen (defined as having progressed/grown through bevacizumab by RANO criteria within 2 months of prior bevacizumab treatment) will receive Sym004 intravenously every two weeks.
Sym004 - 18 mg/kg: Sym004 was dosed at 18 mg/kg intravenously every two weeks.
|
Non-bevacizumab Failures - 24 mg/kg
n=5 Participants
Non-bevacizumab failure (either no prior bevacizumab or bevacizumab stable/responder, which is defined as stable for at least 6 months from prior treatment with bevacizumab without experiencing a bevacizumab adverse event of special interest (AESI) while on a bevacizumab-containing regimen) will receive Sym004 intravenously every two weeks.
Sym004 - 24 mg/kg: Beginning in August 2017, the dose was increased to 24 mg/kg intravenously every two weeks.
|
Bevacizumab Failures - 24 mg/kg
n=7 Participants
Prior progression on a bevacizumab-containing regimen (defined as having progressed/grown through bevacizumab by RANO criteria within 2 months of prior bevacizumab treatment) will receive Sym004 intravenously every two weeks.
Sym004 - 24 mg/kg: Beginning in August 2017, the dose was increased to 24 mg/kg intravenously every two weeks.
|
|---|---|---|---|---|
|
Median Overall Survival (OS)
|
7.54 months
Interval 3.88 to 10.81
|
5.51 months
Interval 1.87 to 8.8
|
9.95 months
Interval 4.17 to 15.54
|
5.39 months
Interval 0.85 to 8.64
|
Adverse Events
Non-bevacizumab Failures - 18 mg/kg
Serious events: 8 serious events
Other events: 20 other events
Deaths: 20 deaths
Bevacizumab Failures - 18 mg/kg
Serious events: 2 serious events
Other events: 7 other events
Deaths: 7 deaths
Non-bevacizumab Failures - 24 mg/kg
Serious events: 2 serious events
Other events: 5 other events
Deaths: 5 deaths
Bevacizumab Failures - 24 mg/kg
Serious events: 4 serious events
Other events: 7 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Non-bevacizumab Failures - 18 mg/kg
n=20 participants at risk
Non-bevacizumab failure (either no prior bevacizumab or bevacizumab stable/responder, which is defined as stable for at least 6 months from prior treatment with bevacizumab without experiencing a bevacizumab adverse event of special interest (AESI) while on a bevacizumab-containing regimen) will receive Sym004 intravenously every two weeks.
Sym004: Sym004 was dosed at 18 mg/kg intravenously every two weeks.
|
Bevacizumab Failures - 18 mg/kg
n=7 participants at risk
Prior progression on a bevacizumab-containing regimen (defined as having progressed/grown through bevacizumab by RANO criteria within 2 months of prior bevacizumab treatment) will receive Sym004 intravenously every two weeks.
Sym004: Sym004 was dosed at 18 mg/kg intravenously every two weeks. .
|
Non-bevacizumab Failures - 24 mg/kg
n=5 participants at risk
Non-bevacizumab failure (either no prior bevacizumab or bevacizumab stable/responder, which is defined as stable for at least 6 months from prior treatment with bevacizumab without experiencing a bevacizumab adverse event of special interest (AESI) while on a bevacizumab-containing regimen) will receive Sym004 intravenously every two weeks.
Beginning in August 2017, the dose was increased to 24 mg/kg intravenously every two weeks.
|
Bevacizumab Failures - 24 mg/kg
n=7 participants at risk
Prior progression on a bevacizumab-containing regimen (defined as having progressed/grown through bevacizumab by RANO criteria within 2 months of prior bevacizumab treatment) will receive Sym004 intravenously every two weeks.
Beginning in August 2017, the dose was increased to 24 mg/kg intravenously every two weeks.
|
|---|---|---|---|---|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
General disorders
Edema limbs
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
General disorders
Fatigue
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Infections and infestations
Catheter related infection
|
5.0%
1/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Infections and infestations
Infections and infestations - Other, Specify: FEVER
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Infections and infestations
Papulopustular rash
|
5.0%
1/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Infections and infestations
Sepsis
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, Specify: CHARGED/HEADBUTTED BY BULL
|
5.0%
1/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
5.0%
1/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Specify
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Nervous system disorders
Dysphasia
|
5.0%
1/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Nervous system disorders
Seizure
|
20.0%
4/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
40.0%
2/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Psychiatric disorders
Confusion
|
5.0%
1/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, Specify: NEPHROLITHIASIS
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.0%
1/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.0%
1/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Vascular disorders
Thromboembolic event
|
5.0%
1/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
Other adverse events
| Measure |
Non-bevacizumab Failures - 18 mg/kg
n=20 participants at risk
Non-bevacizumab failure (either no prior bevacizumab or bevacizumab stable/responder, which is defined as stable for at least 6 months from prior treatment with bevacizumab without experiencing a bevacizumab adverse event of special interest (AESI) while on a bevacizumab-containing regimen) will receive Sym004 intravenously every two weeks.
Sym004: Sym004 was dosed at 18 mg/kg intravenously every two weeks.
|
Bevacizumab Failures - 18 mg/kg
n=7 participants at risk
Prior progression on a bevacizumab-containing regimen (defined as having progressed/grown through bevacizumab by RANO criteria within 2 months of prior bevacizumab treatment) will receive Sym004 intravenously every two weeks.
Sym004: Sym004 was dosed at 18 mg/kg intravenously every two weeks. .
|
Non-bevacizumab Failures - 24 mg/kg
n=5 participants at risk
Non-bevacizumab failure (either no prior bevacizumab or bevacizumab stable/responder, which is defined as stable for at least 6 months from prior treatment with bevacizumab without experiencing a bevacizumab adverse event of special interest (AESI) while on a bevacizumab-containing regimen) will receive Sym004 intravenously every two weeks.
Beginning in August 2017, the dose was increased to 24 mg/kg intravenously every two weeks.
|
Bevacizumab Failures - 24 mg/kg
n=7 participants at risk
Prior progression on a bevacizumab-containing regimen (defined as having progressed/grown through bevacizumab by RANO criteria within 2 months of prior bevacizumab treatment) will receive Sym004 intravenously every two weeks.
Beginning in August 2017, the dose was increased to 24 mg/kg intravenously every two weeks.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
15.0%
3/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
40.0%
2/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Cardiac disorders
Cardiac disorders - Other, Specify: TACHYCARDIA
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
20.0%
1/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
20.0%
1/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, Specify: "EAR FULLNESS/SWELLING" FEELING
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, Specify: EAR DISCHARGE
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
20.0%
1/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, Specify: INTERMITTENT FEELING OF WATER IN EARS
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Ear and labyrinth disorders
Ear pain
|
5.0%
1/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
20.0%
1/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Eye disorders
Blurred vision
|
5.0%
1/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
20.0%
1/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Eye disorders
Conjunctivitis
|
5.0%
1/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
20.0%
1/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Eye disorders
Dry eye
|
5.0%
1/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Eye disorders
Eye disorders - Other, Specify: "BLURRED", EYES CLOSED MOST TIMES
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Eye disorders
Eye disorders - Other, Specify: DECREASED VISION
|
5.0%
1/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Eye disorders
Eye disorders - Other, Specify: DIPLOPIA
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
20.0%
1/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Eye disorders
Eye disorders - Other, Specify: EYELID ITCHING, RIGHT EYE REDNESS, CRUSTING TO EYES
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
20.0%
1/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Eye disorders
Eye disorders - Other, Specify: HEMIANOPIA
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
20.0%
1/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Eye disorders
Eye disorders - Other, Specify: L EYE WITH DRAINAGE; CRUST AROUND EYELID
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Gastrointestinal disorders
Anal hemorrhage
|
5.0%
1/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Gastrointestinal disorders
Constipation
|
15.0%
3/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
4/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
40.0%
2/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Gastrointestinal disorders
Dry mouth
|
5.0%
1/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
20.0%
1/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Gastrointestinal disorders
Dysphagia
|
10.0%
2/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Gastrointestinal disorders
Fecal incontinence
|
5.0%
1/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, Specify: GLOSSITIS
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
20.0%
1/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, Specify: HYPERSALIVATION
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
20.0%
1/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, Specify: MOUTH SORES
|
5.0%
1/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
5.0%
1/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
4/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
20.0%
1/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Gastrointestinal disorders
Oral pain
|
5.0%
1/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
20.0%
1/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Gastrointestinal disorders
Vomiting
|
15.0%
3/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
20.0%
1/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
General disorders
Chills
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
40.0%
2/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
General disorders
Edema face
|
5.0%
1/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
20.0%
1/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
General disorders
Edema limbs
|
5.0%
1/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
General disorders
Fatigue
|
35.0%
7/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
28.6%
2/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
60.0%
3/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
28.6%
2/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
General disorders
Flu like symptoms
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
20.0%
1/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
General disorders
Gait disturbance
|
5.0%
1/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
20.0%
1/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
General disorders
General disorders and administration site conditions - Other, Specify: CHILLS
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
20.0%
1/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
General disorders
General disorders and administration site conditions - Other, Specify: RUNNY NOSE
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
20.0%
1/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
General disorders
Infusion related reaction
|
15.0%
3/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
28.6%
2/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
20.0%
1/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
28.6%
2/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
General disorders
Irritability
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
General disorders
Pain
|
20.0%
4/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
40.0%
2/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
28.6%
2/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Infections and infestations
Infections and infestations - Other, Specify: BACTEREMIA
|
5.0%
1/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Infections and infestations
Infections and infestations - Other, Specify: FUNGAL RASH
|
5.0%
1/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Infections and infestations
Infections and infestations - Other, Specify: MRSA INFECTION
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
20.0%
1/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Infections and infestations
Otitis media
|
5.0%
1/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Infections and infestations
Papulopustular rash
|
10.0%
2/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Infections and infestations
Paronychia
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
20.0%
1/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Infections and infestations
Sinusitis
|
5.0%
1/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Infections and infestations
Skin infection
|
15.0%
3/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
20.0%
1/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Infections and infestations
Soft tissue infection
|
5.0%
1/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Infections and infestations
Upper respiratory infection
|
5.0%
1/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Infections and infestations
Urinary tract infection
|
5.0%
1/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Injury, poisoning and procedural complications
Burn
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Injury, poisoning and procedural complications
Fall
|
20.0%
4/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
20.0%
1/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, Specify: LACERATION TO RIGHT LOWER LEG
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
20.0%
1/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, Specify: WOUND FROM FALL; DRAINAGE
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Investigations
Alanine aminotransferase increased
|
15.0%
3/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
28.6%
2/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
28.6%
2/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Investigations
Alkaline phosphatase increased
|
20.0%
4/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
28.6%
2/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
20.0%
1/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Investigations
Aspartate aminotransferase increased
|
5.0%
1/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
20.0%
1/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
28.6%
2/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Investigations
Creatinine increased
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
20.0%
1/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Investigations
Lymphocyte count decreased
|
25.0%
5/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
20.0%
1/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
28.6%
2/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
28.6%
2/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Investigations
Platelet count decreased
|
5.0%
1/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
57.1%
4/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Investigations
Weight loss
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Investigations
White blood cell decreased
|
5.0%
1/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Metabolism and nutrition disorders
Anorexia
|
15.0%
3/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.0%
1/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
40.0%
8/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
28.6%
2/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
80.0%
4/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
42.9%
3/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
55.0%
11/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
42.9%
3/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
60.0%
3/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
28.6%
2/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
40.0%
8/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
42.9%
3/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
80.0%
4/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
57.1%
4/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
40.0%
8/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
28.6%
2/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
20.0%
1/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
65.0%
13/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
71.4%
5/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
80.0%
4/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
42.9%
3/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
10.0%
2/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
40.0%
2/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.0%
1/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
5.0%
1/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
28.6%
2/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
20.0%
1/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
5.0%
1/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Nervous system disorders
Dizziness
|
5.0%
1/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
20.0%
1/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
28.6%
2/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Nervous system disorders
Dysphasia
|
15.0%
3/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Nervous system disorders
Headache
|
35.0%
7/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
28.6%
2/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
40.0%
2/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
20.0%
1/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
28.6%
2/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Nervous system disorders
Nervous system disorders - Other, Specify: DIFFICULTY HOLDING ITEMS WITH HIS LEFT HAND
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
20.0%
1/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Nervous system disorders
Nervous system disorders - Other, Specify: DISORIENTATION
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
20.0%
1/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Nervous system disorders
Nervous system disorders - Other, Specify: WEAKNESS, BALANCE OFF
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Nervous system disorders
Neuralgia
|
5.0%
1/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
28.6%
2/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Nervous system disorders
Pyramidal tract syndrome
|
5.0%
1/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
20.0%
1/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Nervous system disorders
Seizure
|
30.0%
6/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
57.1%
4/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
40.0%
2/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Nervous system disorders
Tremor
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
40.0%
2/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Psychiatric disorders
Confusion
|
5.0%
1/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
20.0%
1/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
42.9%
3/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Psychiatric disorders
Depression
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Psychiatric disorders
Insomnia
|
5.0%
1/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
20.0%
1/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
20.0%
1/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Renal and urinary disorders
Hematuria
|
10.0%
2/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
28.6%
2/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
20.0%
1/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, Specify: DISCOLORED URINE
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Renal and urinary disorders
Urinary incontinence
|
5.0%
1/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
20.0%
1/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
1/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
40.0%
2/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.0%
1/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
20.0%
1/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.0%
1/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
28.6%
2/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
10.0%
2/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.0%
2/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
25.0%
5/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
20.0%
1/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
5.0%
1/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
20.0%
1/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
2/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
80.0%
4/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
15.0%
3/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
40.0%
2/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
28.6%
2/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
65.0%
13/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
85.7%
6/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
80.0%
4/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
57.1%
4/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Specify: INDEX FINGER CUTICLE REDNESS/IRRITATION
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
20.0%
1/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Specify: "BRUISING APPEARANCE"
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Specify
|
5.0%
1/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Specify: "REDNESS TO CHEEKS"
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
20.0%
1/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Specify: FACIAL REDNESS
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Specify: HEELS CRACKED WITH SCABBING AND BRUISING
|
5.0%
1/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Specify: RASH
|
15.0%
3/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
20.0%
1/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Specify: RED PATCHY SPOTS/WHITE HEAD ON NOSE
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Specify: SENSITIVE FEET
|
5.0%
1/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Specify: SKIN TEARS
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Specify: SKIN TRAUMA
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
20.0%
1/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Specify: SOME NAILBEDS OF FINGERS REDDENED
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Specify: SORE, INFLAMED AREA BEHIND L EAR
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
20.0%
1/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Specify: SUNBURN
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
5.0%
1/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Vascular disorders
Hypertension
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
20.0%
1/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
14.3%
1/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Vascular disorders
Hypotension
|
10.0%
2/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/20 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
28.6%
2/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/5 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
0.00%
0/7 • From the start of study treatment for a patient until 30 days after treatment is discontinued, maximum of 1 year.
Patients were evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place