Trial Outcomes & Findings for Fractionated Stereotactic Radiosurgery for Large Brain Metastases (NCT NCT02054689)
NCT ID: NCT02054689
Last Updated: 2025-05-28
Results Overview
The number of patients experiencing DLT, defined as the maximum amount of Gy fractionated stereotactic radiosurgery (FSRS) delivered without significant toxicity.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Up to 3 years
Results posted on
2025-05-28
Participant Flow
Participant milestones
| Measure |
Fractionated Stereotactic Radiosurgery - 24Gy
24 Gy in 3 fractions (8-12 Gy/fx).
Fractionated Stereotactic Radiosurgery: SRS SBRT CyberKnife Trilogy True Beam Radiosurgery
|
Fractionated Stereotactic Radiosurgery - 27Gy
27 Gy in 3 fractions (8-12 Gy/fx).
Fractionated Stereotactic Radiosurgery: SRS SBRT CyberKnife Trilogy True Beam Radiosurgery
|
Fractionated Stereotactic Radiosurgery - 30 Gy
30 Gy in 3 fractions (8-12 Gy/fx).
Fractionated Stereotactic Radiosurgery: SRS SBRT CyberKnife Trilogy True Beam Radiosurgery
|
Fractionated Stereotactic Radiosurgery - 33 Gy
33 Gy in 3 fractions (8-12 Gy/fx).
Fractionated Stereotactic Radiosurgery: SRS SBRT CyberKnife Trilogy True Beam Radiosurgery
|
Fractionated Stereotactic Radiosurgery - 36 Gy
36 Gy in 3 fractions (8-12 Gy/fx).
Fractionated Stereotactic Radiosurgery: SRS SBRT CyberKnife Trilogy True Beam
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
2
|
3
|
2
|
9
|
|
Overall Study
COMPLETED
|
4
|
2
|
3
|
2
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fractionated Stereotactic Radiosurgery for Large Brain Metastases
Baseline characteristics by cohort
| Measure |
Fractionated Stereotactic Radiosurgery - 24 Gy
n=4 Participants
24 Gy in 3 fractions (8-12 Gy/fx).
Fractionated Stereotactic Radiosurgery: SRS SBRT CyberKnife Trilogy True Beam Radiosurgery
|
Fractionated Stereotactic Radiosurgery - 27 Gy
n=2 Participants
27 Gy in 3 fractions (8-12 Gy/fx).
Fractionated Stereotactic Radiosurgery: SRS SBRT CyberKnife Trilogy True Beam Radiosurgery
|
Fractionated Stereotactic Radiosurgery - 30 Gy
n=3 Participants
30 Gy in 3 fractions (8-12 Gy/fx).
Fractionated Stereotactic Radiosurgery: SRS SBRT CyberKnife Trilogy True Beam Radiosurgery
|
Fractionated Stereotactic Radiosurgery - 33 Gy
n=2 Participants
33 Gy in 3 fractions (8-12 Gy/fx).
Fractionated Stereotactic Radiosurgery: SRS SBRT CyberKnife Trilogy True Beam Radiosurgery
|
Fractionated Stereotactic Radiosurgery - 36 Gy
n=9 Participants
36 Gy in 3 fractions (8-12 Gy/fx).
Fractionated Stereotactic Radiosurgery: SRS SBRT CyberKnife Trilogy True Beam Radiosurgery
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
69.5 years
n=5 Participants
|
66.5 years
n=7 Participants
|
54.0 years
n=5 Participants
|
61.5 years
n=4 Participants
|
65.0 years
n=21 Participants
|
67.0 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Up to 3 yearsPopulation: All treated patients.
The number of patients experiencing DLT, defined as the maximum amount of Gy fractionated stereotactic radiosurgery (FSRS) delivered without significant toxicity.
Outcome measures
| Measure |
Fractionated Stereotactic Radiosurgery - 24 Gy
n=4 Participants
24 Gy in 3 fractions (8-12 Gy/fx).
Fractionated Stereotactic Radiosurgery: SRS SBRT CyberKnife Trilogy True Beam Radiosurgery
|
Fractionated Stereotactic Radiosurgery - 27 Gy
n=2 Participants
27 Gy in 3 fractions (8-12 Gy/fx).
Fractionated Stereotactic Radiosurgery: SRS SBRT CyberKnife Trilogy True Beam Radiosurgery
|
Fractionated Stereotactic Radiosurgery - 30 Gy
n=3 Participants
30 Gy in 3 fractions (8-12 Gy/fx).
Fractionated Stereotactic Radiosurgery: SRS SBRT CyberKnife Trilogy True Beam Radiosurgery
|
Fractionated Stereotactic Radiosurgery - 33 Gy
n=2 Participants
33 Gy in 3 fractions (8-12 Gy/fx).
Fractionated Stereotactic Radiosurgery: SRS SBRT CyberKnife Trilogy True Beam Radiosurgery
|
Fractionated Stereotactic Radiosurgery - 36 Gy
n=9 Participants
36 Gy in 3 fractions (8-12 Gy/fx).
Fractionated Stereotactic Radiosurgery: SRS SBRT CyberKnife Trilogy True Beam Radiosurgery
|
|---|---|---|---|---|---|
|
Number of Patients Experiencing DLT
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Up to 24 months post completion of treatmentPopulation: All treated patients evaluable for DLTs
The MTD was determined following a Time-to-Event Continual Reassessment Model which models toxicity as a function of dose. Treatment was given in 3 fractions (8-12 Gy/fx).
Outcome measures
| Measure |
Fractionated Stereotactic Radiosurgery - 24 Gy
n=20 Participants
24 Gy in 3 fractions (8-12 Gy/fx).
Fractionated Stereotactic Radiosurgery: SRS SBRT CyberKnife Trilogy True Beam Radiosurgery
|
Fractionated Stereotactic Radiosurgery - 27 Gy
27 Gy in 3 fractions (8-12 Gy/fx).
Fractionated Stereotactic Radiosurgery: SRS SBRT CyberKnife Trilogy True Beam Radiosurgery
|
Fractionated Stereotactic Radiosurgery - 30 Gy
30 Gy in 3 fractions (8-12 Gy/fx).
Fractionated Stereotactic Radiosurgery: SRS SBRT CyberKnife Trilogy True Beam Radiosurgery
|
Fractionated Stereotactic Radiosurgery - 33 Gy
33 Gy in 3 fractions (8-12 Gy/fx).
Fractionated Stereotactic Radiosurgery: SRS SBRT CyberKnife Trilogy True Beam Radiosurgery
|
Fractionated Stereotactic Radiosurgery - 36 Gy
36 Gy in 3 fractions (8-12 Gy/fx).
Fractionated Stereotactic Radiosurgery: SRS SBRT CyberKnife Trilogy True Beam Radiosurgery
|
|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD)
|
36 Gy
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 24 months after completion of treatmentPopulation: Treated patients who were radiologically evaluable.
Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) in the target lesion, or Progressive Disease (PD) per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progression).
Outcome measures
| Measure |
Fractionated Stereotactic Radiosurgery - 24 Gy
n=4 Participants
24 Gy in 3 fractions (8-12 Gy/fx).
Fractionated Stereotactic Radiosurgery: SRS SBRT CyberKnife Trilogy True Beam Radiosurgery
|
Fractionated Stereotactic Radiosurgery - 27 Gy
n=2 Participants
27 Gy in 3 fractions (8-12 Gy/fx).
Fractionated Stereotactic Radiosurgery: SRS SBRT CyberKnife Trilogy True Beam Radiosurgery
|
Fractionated Stereotactic Radiosurgery - 30 Gy
n=3 Participants
30 Gy in 3 fractions (8-12 Gy/fx).
Fractionated Stereotactic Radiosurgery: SRS SBRT CyberKnife Trilogy True Beam Radiosurgery
|
Fractionated Stereotactic Radiosurgery - 33 Gy
n=2 Participants
33 Gy in 3 fractions (8-12 Gy/fx).
Fractionated Stereotactic Radiosurgery: SRS SBRT CyberKnife Trilogy True Beam Radiosurgery
|
Fractionated Stereotactic Radiosurgery - 36 Gy
n=9 Participants
36 Gy in 3 fractions (8-12 Gy/fx).
Fractionated Stereotactic Radiosurgery: SRS SBRT CyberKnife Trilogy True Beam Radiosurgery
|
|---|---|---|---|---|---|
|
Best Response
Partial Response
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Best Response
Stable Disease
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Best Response
Progressive Disease
|
3 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
|
Best Response
Complete Response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 24 months after completion of treatmentPopulation: Treated patients who were radiologically evaluable.
Percentage of patients with local control, defined as stable disease (SD), partial response (PR), or complete response (CR) in the target lesion, per RECIST v1.1. Complete Response (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm., Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
Fractionated Stereotactic Radiosurgery - 24 Gy
n=4 Participants
24 Gy in 3 fractions (8-12 Gy/fx).
Fractionated Stereotactic Radiosurgery: SRS SBRT CyberKnife Trilogy True Beam Radiosurgery
|
Fractionated Stereotactic Radiosurgery - 27 Gy
n=2 Participants
27 Gy in 3 fractions (8-12 Gy/fx).
Fractionated Stereotactic Radiosurgery: SRS SBRT CyberKnife Trilogy True Beam Radiosurgery
|
Fractionated Stereotactic Radiosurgery - 30 Gy
n=3 Participants
30 Gy in 3 fractions (8-12 Gy/fx).
Fractionated Stereotactic Radiosurgery: SRS SBRT CyberKnife Trilogy True Beam Radiosurgery
|
Fractionated Stereotactic Radiosurgery - 33 Gy
n=2 Participants
33 Gy in 3 fractions (8-12 Gy/fx).
Fractionated Stereotactic Radiosurgery: SRS SBRT CyberKnife Trilogy True Beam Radiosurgery
|
Fractionated Stereotactic Radiosurgery - 36 Gy
n=9 Participants
36 Gy in 3 fractions (8-12 Gy/fx).
Fractionated Stereotactic Radiosurgery: SRS SBRT CyberKnife Trilogy True Beam Radiosurgery
|
|---|---|---|---|---|---|
|
Local Control of Disease
Local Control - Yes
|
25 percentage of participants
|
50 percentage of participants
|
66.7 percentage of participants
|
0 percentage of participants
|
55.6 percentage of participants
|
|
Local Control of Disease
Local Control - No
|
75 percentage of participants
|
50 percentage of participants
|
33.3 percentage of participants
|
100 percentage of participants
|
44.4 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 24 months after completion of treatmentPopulation: Treated patients who were radiologically evaluable.
Percentage of patients who develop new lesions outside the target volume. Patients without follow-up scans are excluded as it is not known if they developed lesions outside the target volume.
Outcome measures
| Measure |
Fractionated Stereotactic Radiosurgery - 24 Gy
n=4 Participants
24 Gy in 3 fractions (8-12 Gy/fx).
Fractionated Stereotactic Radiosurgery: SRS SBRT CyberKnife Trilogy True Beam Radiosurgery
|
Fractionated Stereotactic Radiosurgery - 27 Gy
n=2 Participants
27 Gy in 3 fractions (8-12 Gy/fx).
Fractionated Stereotactic Radiosurgery: SRS SBRT CyberKnife Trilogy True Beam Radiosurgery
|
Fractionated Stereotactic Radiosurgery - 30 Gy
n=3 Participants
30 Gy in 3 fractions (8-12 Gy/fx).
Fractionated Stereotactic Radiosurgery: SRS SBRT CyberKnife Trilogy True Beam Radiosurgery
|
Fractionated Stereotactic Radiosurgery - 33 Gy
n=2 Participants
33 Gy in 3 fractions (8-12 Gy/fx).
Fractionated Stereotactic Radiosurgery: SRS SBRT CyberKnife Trilogy True Beam Radiosurgery
|
Fractionated Stereotactic Radiosurgery - 36 Gy
n=9 Participants
36 Gy in 3 fractions (8-12 Gy/fx).
Fractionated Stereotactic Radiosurgery: SRS SBRT CyberKnife Trilogy True Beam Radiosurgery
|
|---|---|---|---|---|---|
|
Regional Intracranial Failure
No
|
50 percentage of patients
|
0 percentage of patients
|
33.3 percentage of patients
|
50 percentage of patients
|
55.6 percentage of patients
|
|
Regional Intracranial Failure
Yes
|
25 percentage of patients
|
100 percentage of patients
|
66.7 percentage of patients
|
0 percentage of patients
|
22.2 percentage of patients
|
|
Regional Intracranial Failure
Unknown - no FU scans
|
25 percentage of patients
|
0 percentage of patients
|
0 percentage of patients
|
50 percentage of patients
|
22.2 percentage of patients
|
SECONDARY outcome
Timeframe: Prior to treatment; 30 days post treatment; 8 -12 weeks, 22-28 weeks, 30-42 weeks, 45-60 weeks, 64-74 weeks, 80-84 weeks, 90-96 weeks,100-112 weeks, 120-124 weeks, 130-140 weeks, 145-155 weeks, and 160-170 weeks post treatmentPopulation: All participants who provided self-administered QoL surveys.
Functional Assessment of Cancer Therapy - Brain (FACT-Br) is a 50 item, self-administered questionnaire used to assess Quality of Life, including, Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. Subscale scores range from 0-4. FACT-G = (PWB - 7 items, score range 0-28) + (SWB - 7 items, score range 0-28) + (EWB - 6 items, score 0-24) + (FWB - 7 items, 0-28). The assessment takes 10-15 minutes to completed and is scored using a 5-point Likert-type scale. Scores range from 0-108, with higher scores indicating better Quality of Life.
Outcome measures
| Measure |
Fractionated Stereotactic Radiosurgery - 24 Gy
n=4 Participants
24 Gy in 3 fractions (8-12 Gy/fx).
Fractionated Stereotactic Radiosurgery: SRS SBRT CyberKnife Trilogy True Beam Radiosurgery
|
Fractionated Stereotactic Radiosurgery - 27 Gy
n=2 Participants
27 Gy in 3 fractions (8-12 Gy/fx).
Fractionated Stereotactic Radiosurgery: SRS SBRT CyberKnife Trilogy True Beam Radiosurgery
|
Fractionated Stereotactic Radiosurgery - 30 Gy
n=3 Participants
30 Gy in 3 fractions (8-12 Gy/fx).
Fractionated Stereotactic Radiosurgery: SRS SBRT CyberKnife Trilogy True Beam Radiosurgery
|
Fractionated Stereotactic Radiosurgery - 33 Gy
n=2 Participants
33 Gy in 3 fractions (8-12 Gy/fx).
Fractionated Stereotactic Radiosurgery: SRS SBRT CyberKnife Trilogy True Beam Radiosurgery
|
Fractionated Stereotactic Radiosurgery - 36 Gy
n=9 Participants
36 Gy in 3 fractions (8-12 Gy/fx).
Fractionated Stereotactic Radiosurgery: SRS SBRT CyberKnife Trilogy True Beam Radiosurgery
|
|---|---|---|---|---|---|
|
Functional Assessment of Cancer Therapy - Brain (FACT-Br)
Prior to treatment
|
76 score on a scale
Standard Deviation 21
|
83 score on a scale
Standard Deviation 13
|
76 score on a scale
Standard Deviation 12
|
59 score on a scale
Standard Deviation 25
|
77 score on a scale
Standard Deviation 14
|
|
Functional Assessment of Cancer Therapy - Brain (FACT-Br)
30 days post treatment
|
82 score on a scale
Standard Deviation 9
|
79 score on a scale
Standard Deviation 18
|
76 score on a scale
Standard Deviation NA
insufficient number of participants with completed QoL assessment
|
—
|
79 score on a scale
Standard Deviation 23
|
|
Functional Assessment of Cancer Therapy - Brain (FACT-Br)
130-140 weeks post treatment
|
106 score on a scale
Standard Deviation NA
insufficient number of participants with completed QoL assessment
|
—
|
—
|
—
|
—
|
|
Functional Assessment of Cancer Therapy - Brain (FACT-Br)
8-16 weeks post treatment
|
81 score on a scale
Standard Deviation 14
|
84 score on a scale
Standard Deviation 5
|
83 score on a scale
Standard Deviation 2
|
—
|
87 score on a scale
Standard Deviation 10
|
|
Functional Assessment of Cancer Therapy - Brain (FACT-Br)
22-28 weeks post treatment
|
85 score on a scale
Standard Deviation 14
|
—
|
78 score on a scale
Standard Deviation 2
|
—
|
78 score on a scale
Standard Deviation NA
insufficient number of participants with completed QoL assessment
|
|
Functional Assessment of Cancer Therapy - Brain (FACT-Br)
30-42 weeks post treatment
|
90 score on a scale
Standard Deviation 11
|
92 score on a scale
Standard Deviation NA
insufficient number of participants with completed QoL assessment
|
85 score on a scale
Standard Deviation 6
|
—
|
59 score on a scale
Standard Deviation NA
insufficient number of participants with completed QoL assessment
|
|
Functional Assessment of Cancer Therapy - Brain (FACT-Br)
45-60 weeks post treatment
|
98 score on a scale
Standard Deviation NA
insufficient number of participants with completed QoL assessment
|
94 score on a scale
Standard Deviation NA
insufficient number of participants with completed QoL assessment
|
83 score on a scale
Standard Deviation NA
insufficient number of participants with completed QoL assessment
|
—
|
—
|
|
Functional Assessment of Cancer Therapy - Brain (FACT-Br)
64-74 weeks post treatment
|
95 score on a scale
Standard Deviation NA
insufficient number of participants with completed QoL assessment
|
101 score on a scale
Standard Deviation NA
insufficient number of participants with completed QoL assessment
|
62 score on a scale
Standard Deviation NA
insufficient number of participants with completed QoL assessment
|
—
|
79 score on a scale
Standard Deviation NA
insufficient number of participants with completed QoL assessment
|
|
Functional Assessment of Cancer Therapy - Brain (FACT-Br)
80-84 weeks post treatment
|
—
|
102 score on a scale
Standard Deviation NA
insufficient number of participants with completed QoL assessment
|
64 score on a scale
Standard Deviation NA
insufficient number of participants with completed QoL assessment
|
—
|
—
|
|
Functional Assessment of Cancer Therapy - Brain (FACT-Br)
90-96 weeks post treatment
|
—
|
90 score on a scale
Standard Deviation NA
insufficient number of participants with completed QoL assessment
|
—
|
—
|
—
|
|
Functional Assessment of Cancer Therapy - Brain (FACT-Br)
100-112 weeks post treatment
|
98 score on a scale
Standard Deviation NA
insufficient number of participants with completed QoL assessment
|
—
|
—
|
—
|
—
|
|
Functional Assessment of Cancer Therapy - Brain (FACT-Br)
120-124 weeks post treatment
|
104 score on a scale
Standard Deviation NA
insufficient number of participants with completed QoL assessment
|
—
|
—
|
—
|
—
|
|
Functional Assessment of Cancer Therapy - Brain (FACT-Br)
145-155 weeks post treatment
|
100 score on a scale
Standard Deviation NA
insufficient number of participants with completed QoL assessment
|
—
|
—
|
—
|
—
|
|
Functional Assessment of Cancer Therapy - Brain (FACT-Br)
160-170 weeks post treatment
|
99 score on a scale
Standard Deviation NA
insufficient number of participants with completed QoL assessment
|
—
|
—
|
—
|
—
|
Adverse Events
Fractionated Stereotactic Radiosurgery - 24 Gy
Serious events: 1 serious events
Other events: 3 other events
Deaths: 4 deaths
Fractionated Stereotactic Radiosurgery - 27 Gy
Serious events: 0 serious events
Other events: 2 other events
Deaths: 1 deaths
Fractionated Stereotactic Radiosurgery - 30 Gy
Serious events: 0 serious events
Other events: 3 other events
Deaths: 3 deaths
Fractionated Stereotactic Radiosurgery - 33 Gy
Serious events: 0 serious events
Other events: 2 other events
Deaths: 2 deaths
Fractionated Stereotactic Radiosurgery - 36 Gy
Serious events: 0 serious events
Other events: 9 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Fractionated Stereotactic Radiosurgery - 24 Gy
n=4 participants at risk
24 Gy in 3 fractions (8-12 Gy/fx).
Fractionated Stereotactic Radiosurgery: SRS SBRT CyberKnife Trilogy True Beam Radiosurgery
|
Fractionated Stereotactic Radiosurgery - 27 Gy
n=2 participants at risk；n=3 participants at risk
27 Gy in 3 fractions (8-12 Gy/fx).
Fractionated Stereotactic Radiosurgery: SRS SBRT CyberKnife Trilogy True Beam Radiosurgery
|
Fractionated Stereotactic Radiosurgery - 30 Gy
n=3 participants at risk；n=2 participants at risk
30 Gy in 3 fractions (8-12 Gy/fx).
Fractionated Stereotactic Radiosurgery: SRS SBRT CyberKnife Trilogy True Beam Radiosurgery
|
Fractionated Stereotactic Radiosurgery - 33 Gy
n=2 participants at risk；n=3 participants at risk
33 Gy in 3 fractions (8-12 Gy/fx).
Fractionated Stereotactic Radiosurgery: SRS SBRT CyberKnife Trilogy True Beam Radiosurgery
|
Fractionated Stereotactic Radiosurgery - 36 Gy
n=9 participants at risk
36 Gy in 3 fractions (8-12 Gy/fx).
Fractionated Stereotactic Radiosurgery: SRS SBRT CyberKnife Trilogy True Beam Radiosurgery
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
25.0%
1/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
Other adverse events
| Measure |
Fractionated Stereotactic Radiosurgery - 24 Gy
n=4 participants at risk
24 Gy in 3 fractions (8-12 Gy/fx).
Fractionated Stereotactic Radiosurgery: SRS SBRT CyberKnife Trilogy True Beam Radiosurgery
|
Fractionated Stereotactic Radiosurgery - 27 Gy
n=2 participants at risk；n=3 participants at risk
27 Gy in 3 fractions (8-12 Gy/fx).
Fractionated Stereotactic Radiosurgery: SRS SBRT CyberKnife Trilogy True Beam Radiosurgery
|
Fractionated Stereotactic Radiosurgery - 30 Gy
n=3 participants at risk；n=2 participants at risk
30 Gy in 3 fractions (8-12 Gy/fx).
Fractionated Stereotactic Radiosurgery: SRS SBRT CyberKnife Trilogy True Beam Radiosurgery
|
Fractionated Stereotactic Radiosurgery - 33 Gy
n=2 participants at risk；n=3 participants at risk
33 Gy in 3 fractions (8-12 Gy/fx).
Fractionated Stereotactic Radiosurgery: SRS SBRT CyberKnife Trilogy True Beam Radiosurgery
|
Fractionated Stereotactic Radiosurgery - 36 Gy
n=9 participants at risk
36 Gy in 3 fractions (8-12 Gy/fx).
Fractionated Stereotactic Radiosurgery: SRS SBRT CyberKnife Trilogy True Beam Radiosurgery
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
25.0%
1/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Blood and lymphatic system disorders
Anemia
|
25.0%
1/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
66.7%
2/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Cardiac disorders
Sinus tachycardia
|
25.0%
1/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
100.0%
2/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
33.3%
1/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
22.2%
2/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Ear and labyrinth disorders
Vestibular disorder
|
25.0%
1/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Ear and labyrinth disorders
Tinnitus
|
25.0%
1/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Ear and labyrinth disorders
Hearing impaired
|
25.0%
1/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
22.2%
2/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Ear and labyrinth disorders
Ear pain
|
25.0%
1/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
11.1%
1/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Eye disorders
Blurred vision
|
50.0%
2/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
33.3%
1/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
11.1%
1/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
50.0%
1/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
33.3%
1/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
22.2%
2/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
100.0%
2/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
33.3%
1/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
50.0%
1/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
22.2%
2/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Gastrointestinal disorders
Mucositis oral
|
25.0%
1/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
11.1%
1/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
100.0%
2/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
11.1%
1/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
33.3%
1/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
50.0%
1/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
22.2%
2/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
50.0%
1/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
33.3%
1/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
General disorders
Pain
|
0.00%
0/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
33.3%
1/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
50.0%
1/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
22.2%
2/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
General disorders
Non-cardiac chest pain
|
25.0%
1/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
General disorders
Localized edema
|
0.00%
0/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
11.1%
1/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
General disorders
Hypothermia
|
25.0%
1/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
General disorders
General disorders and administration site conditions - Other, specifythrush
|
0.00%
0/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
11.1%
1/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
General disorders
General disorders and administration site conditions - Other, specifylymphadenopathy
|
0.00%
0/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
11.1%
1/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
General disorders
Gait disturbance
|
25.0%
1/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
General disorders
Fever
|
25.0%
1/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
50.0%
1/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
50.0%
1/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
General disorders
Fatigue
|
50.0%
2/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
100.0%
2/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
100.0%
3/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
50.0%
1/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
66.7%
6/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
General disorders
Edema limbs
|
50.0%
2/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
33.3%
1/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
100.0%
2/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
44.4%
4/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
General disorders
Chills
|
25.0%
1/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Infections and infestations
Urinary tract infection
|
25.0%
1/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Infections and infestations
Skin infection
|
0.00%
0/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
11.1%
1/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Infections and infestations
Sepsis
|
25.0%
1/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Infections and infestations
Papulopustular rash
|
0.00%
0/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
11.1%
1/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Infections and infestations
Lung infection
|
25.0%
1/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Infections and infestations
Infections and infestations - Other, specifyThrush
|
0.00%
0/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
50.0%
1/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Injury, poisoning and procedural complications
Fall
|
25.0%
1/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
22.2%
2/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
11.1%
1/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Investigations
Weight gain
|
25.0%
1/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Investigations
Platelet count decreased
|
25.0%
1/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Investigations
Neutrophil count decreased
|
25.0%
1/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Investigations
Lymphocyte count decreased
|
25.0%
1/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
11.1%
1/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
50.0%
1/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
100.0%
2/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
33.3%
1/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
50.0%
1/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
44.4%
4/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specifyrhabdomyolysis
|
25.0%
1/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specifyBursitis
|
0.00%
0/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
33.3%
1/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
11.1%
1/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
25.0%
1/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
33.3%
1/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
50.0%
1/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
25.0%
1/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
33.3%
1/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
33.3%
1/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
33.3%
1/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
50.0%
1/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
11.1%
1/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
33.3%
1/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Nervous system disorders
Tremor
|
0.00%
0/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
11.1%
1/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Nervous system disorders
Somnolence
|
50.0%
2/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Nervous system disorders
Seizure
|
25.0%
1/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
33.3%
1/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Nervous system disorders
Paresthesia
|
25.0%
1/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
50.0%
1/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
33.3%
1/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
11.1%
1/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Nervous system disorders
Nystagmus
|
25.0%
1/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Nervous system disorders
Nervous system disorders - Other, specifyPositive Romberg Sign
|
0.00%
0/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
50.0%
1/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
11.1%
1/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
50.0%
1/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
66.7%
2/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
50.0%
1/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
22.2%
2/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Nervous system disorders
Dysphasia
|
0.00%
0/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
50.0%
1/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
11.1%
1/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
33.3%
1/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
11.1%
1/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Nervous system disorders
Cognitive disturbance
|
25.0%
1/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
33.3%
1/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
11.1%
1/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Nervous system disorders
Ataxia
|
25.0%
1/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
50.0%
1/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
33.3%
1/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
33.3%
3/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Psychiatric disorders
Depression
|
0.00%
0/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
33.3%
1/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
33.3%
1/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
11.1%
1/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Renal and urinary disorders
Urinary incontinence
|
25.0%
1/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specifyNocturia
|
0.00%
0/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
50.0%
1/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Reproductive system and breast disorders
Gynecomastia
|
0.00%
0/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
50.0%
1/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
11.1%
1/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
50.0%
1/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
25.0%
1/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
50.0%
1/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
11.1%
1/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
11.1%
1/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
11.1%
1/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
2/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
50.0%
1/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
66.7%
2/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
100.0%
2/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
44.4%
4/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
2/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
50.0%
1/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
22.2%
2/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
50.0%
1/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
33.3%
1/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
50.0%
1/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
50.0%
1/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
50.0%
1/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
11.1%
1/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
33.3%
1/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
|
Vascular disorders
Hypotension
|
25.0%
1/4 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/3 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/2 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
0.00%
0/9 • Adverse Events data collected for a total of 10 years for the study population. Up to approximately 24 months after start of treatment for individuals.
|
Additional Information
Barbara Stadterman, MPH, MSCCR, CCRP, Clinical Research Manager
UPMC Hillman Cancer Center
Phone: 4126475554
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place