Trial Outcomes & Findings for Hypofractionated Stereotactic Irradiation (HFSRT) With Pembrolizumab and Bevacizumab for Recurrent High Grade Gliomas (NCT NCT02313272)
NCT ID: NCT02313272
Last Updated: 2023-10-23
Results Overview
The pembrolizumab dose used in the dose expansion cohort will be MTD determined from the dose escalation phase. Dose Escalation: The maximum tolerated dose (MTD) is the highest dose of pembrolizumab in combination with bevacizumab after radiation therapy that does not cause unacceptable toxicity in more than one of six patients at that dose level. The MTD is defined as one dose level below the highest toxic dose (i.e., the Dose Limiting Toxicity (DLT) dose).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
Up to 24 months
Results posted on
2023-10-23
Participant Flow
Participant milestones
| Measure |
Dose Level 1: HFSRT With Pembrolizumab and Bevacizumab
Hypofractionated Stereotactic Irradiation (HFSRT) radiation therapy treatment (FSRT) given to participants over 5 days. 100 mg Pembrolizumab intravenous (IV) infusion every 3 weeks. 10 mg/kg Bevacizumab administered intravenously every 2 weeks.
|
Dose Level 2: HRSRT With Pembrolizumb and Bevacizumab
Hypofractionated Stereotactic Irradiation (HFSRT) radiation therapy treatment (FSRT) given to participants over 5 days. 200 mg Pembrolizumab intravenous (IV) infusion every 3 weeks. 10 mg/kg Bevacizumab administered intravenously every 2 weeks.
|
Participants Treated at Maximum Tolerated Dose
Hypofractionated Stereotactic Irradiation (HFSRT) radiation therapy treatment (FSRT) given to participants over 5 days. 200 mg Pembrolizumab intravenous (IV) infusion every 3 weeks. 10 mg/kg Bevacizumab administered intravenously every 2 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
16
|
13
|
|
Overall Study
COMPLETED
|
3
|
16
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hypofractionated Stereotactic Irradiation (HFSRT) With Pembrolizumab and Bevacizumab for Recurrent High Grade Gliomas
Baseline characteristics by cohort
| Measure |
Dose Level 1: HFSRT With Pembrolizumab and Bevacizumab
n=3 Participants
Hypofractionated Stereotactic Irradiation (HFSRT) radiation therapy treatment (FSRT) given to participants over 5 days. 100 mg Pembrolizumab intravenous (IV) infusion every 3 weeks. 10 mg/kg Bevacizumab administered intravenously every 2 weeks.
|
Dose Level 2: HRSRT With Pembrolizumb and Bevacizumab
n=16 Participants
Hypofractionated Stereotactic Irradiation (HFSRT) radiation therapy treatment (FSRT) given to participants over 5 days. 200 mg Pembrolizumab intravenous (IV) infusion every 3 weeks. 10 mg/kg Bevacizumab administered intravenously every 2 weeks.
|
Participants Treated at Maximum Tolerated Dose
n=13 Participants
Hypofractionated Stereotactic Irradiation (HFSRT) radiation therapy treatment (FSRT) given to participants over 5 days. 200 mg Pembrolizumab intravenous (IV) infusion every 3 weeks. 10 mg/kg Bevacizumab administered intravenously every 2 weeks.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
28 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
21 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
29 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
31 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=99 Participants
|
16 participants
n=107 Participants
|
13 participants
n=206 Participants
|
32 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Up to 24 monthsPopulation: Participants in dose finding phase of study
The pembrolizumab dose used in the dose expansion cohort will be MTD determined from the dose escalation phase. Dose Escalation: The maximum tolerated dose (MTD) is the highest dose of pembrolizumab in combination with bevacizumab after radiation therapy that does not cause unacceptable toxicity in more than one of six patients at that dose level. The MTD is defined as one dose level below the highest toxic dose (i.e., the Dose Limiting Toxicity (DLT) dose).
Outcome measures
| Measure |
HFSRT With Pembrolizumab and Bevacizumab
n=19 Participants
Hypofractionated Stereotactic Irradiation (HFSRT). Pembrolizumab intravenous (IV) infusion every 3 weeks. Bevacizumab administered intravenously every 2 weeks.
Hypofractionated Stereotactic Irradiation (HFSRT): Radiation therapy treatment (FSRT) which will be given to participants over 5 days.
Pembrolizumab: Dose Escalation: The dose of pembrolizumab will be escalated per schema in a 3+3 fashion. The starting dose (i.e., dose level 1) will be 100 mg.
Dose Expansion: The pembrolizumab dose used in the dose expansion cohort will be maximum tolerated dose (MTD) determined from the dose escalation phase.
Bevacizumab: Initial cycle of bevacizumab must start within 10 days of registering to the trial. It will be given concurrent with radiation therapy. Bevacizumab will be administered intravenously at a dose of 10 mg/kg every 2 weeks. Doses will be adjusted if there is a \> 10% change in weight.
|
Dose Level 2: HRSRT With Pembrolizumb and Bevacizumab
Hypofractionated Stereotactic Irradiation (HFSRT) radiation therapy treatment (FSRT) given to participants over 5 days. 200 mg Pembrolizumab intravenous (IV) infusion every 3 weeks. 10 mg/kg Bevacizumab administered intravenously every 2 weeks.
|
Participants Treated at Maximum Tolerated Dose
Hypofractionated Stereotactic Irradiation (HFSRT) radiation therapy treatment (FSRT) given to participants over 5 days. 200 mg Pembrolizumab intravenous (IV) infusion every 3 weeks. 10 mg/kg Bevacizumab administered intravenously every 2 weeks.
|
|---|---|---|---|
|
Maximum Tolerated Dose (MTD)
|
200 mg
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: All participants who received at least one dose of study drugs
Response rate of pembrolizumab given in combination with bevacizumab and hypofractionated stereotactic re-irradiation of recurrent high grade gliomas. Response to treatment will be assessed by the investigator and according to the Response Assessment Criteria for High-Grade Gliomas (RANO Criteria). Brain MRI will be performed every 6 weeks beginning at the end of Week 6 (± 1 week) for 3 cycles and then every 12 weeks (± 1 week) until disease progression or treatment discontinuation, whichever occurs later.
Outcome measures
| Measure |
HFSRT With Pembrolizumab and Bevacizumab
n=3 Participants
Hypofractionated Stereotactic Irradiation (HFSRT). Pembrolizumab intravenous (IV) infusion every 3 weeks. Bevacizumab administered intravenously every 2 weeks.
Hypofractionated Stereotactic Irradiation (HFSRT): Radiation therapy treatment (FSRT) which will be given to participants over 5 days.
Pembrolizumab: Dose Escalation: The dose of pembrolizumab will be escalated per schema in a 3+3 fashion. The starting dose (i.e., dose level 1) will be 100 mg.
Dose Expansion: The pembrolizumab dose used in the dose expansion cohort will be maximum tolerated dose (MTD) determined from the dose escalation phase.
Bevacizumab: Initial cycle of bevacizumab must start within 10 days of registering to the trial. It will be given concurrent with radiation therapy. Bevacizumab will be administered intravenously at a dose of 10 mg/kg every 2 weeks. Doses will be adjusted if there is a \> 10% change in weight.
|
Dose Level 2: HRSRT With Pembrolizumb and Bevacizumab
n=16 Participants
Hypofractionated Stereotactic Irradiation (HFSRT) radiation therapy treatment (FSRT) given to participants over 5 days. 200 mg Pembrolizumab intravenous (IV) infusion every 3 weeks. 10 mg/kg Bevacizumab administered intravenously every 2 weeks.
|
Participants Treated at Maximum Tolerated Dose
n=13 Participants
Hypofractionated Stereotactic Irradiation (HFSRT) radiation therapy treatment (FSRT) given to participants over 5 days. 200 mg Pembrolizumab intravenous (IV) infusion every 3 weeks. 10 mg/kg Bevacizumab administered intravenously every 2 weeks.
|
|---|---|---|---|
|
Response Rate (RR)
Complete Response
|
33.33 percentage of participants
|
6.25 percentage of participants
|
0 percentage of participants
|
|
Response Rate (RR)
Partial Response
|
33.33 percentage of participants
|
62.5 percentage of participants
|
71.88 percentage of participants
|
Adverse Events
Dose Level 1: HFSRT With Pembrolizumab and Bevacizumab
Serious events: 3 serious events
Other events: 3 other events
Deaths: 3 deaths
Dose Level 2: HRSRT With Pembrolizumb and Bevacizumab
Serious events: 7 serious events
Other events: 16 other events
Deaths: 14 deaths
Participants Treated at Maximum Tolerated Dose
Serious events: 8 serious events
Other events: 13 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
Dose Level 1: HFSRT With Pembrolizumab and Bevacizumab
n=3 participants at risk
Hypofractionated Stereotactic Irradiation (HFSRT) radiation therapy treatment (FSRT) given to participants over 5 days. 100 mg Pembrolizumab intravenous (IV) infusion every 3 weeks. 10 mg/kg Bevacizumab administered intravenously every 2 weeks.
|
Dose Level 2: HRSRT With Pembrolizumb and Bevacizumab
n=16 participants at risk
Hypofractionated Stereotactic Irradiation (HFSRT) radiation therapy treatment (FSRT) given to participants over 5 days. 200 mg Pembrolizumab intravenous (IV) infusion every 3 weeks. 10 mg/kg Bevacizumab administered intravenously every 2 weeks.
|
Participants Treated at Maximum Tolerated Dose
n=13 participants at risk
Hypofractionated Stereotactic Irradiation (HFSRT) radiation therapy treatment (FSRT) given to participants over 5 days. 200 mg Pembrolizumab intravenous (IV) infusion every 3 weeks. 10 mg/kg Bevacizumab administered intravenously every 2 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Gastrointestinal disorders
Vomitting
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
General disorders
Fever
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
12.5%
2/16 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
15.4%
2/13 • Number of events 3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Infections and infestations
Wound infection
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
18.8%
3/16 • Number of events 6 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Surgical and medical procedures
Surgical and medical procedures-Other
|
66.7%
2/3 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
15.4%
2/13 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
18.8%
3/16 • Number of events 3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Nervous system disorders
Seizure
|
33.3%
1/3 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Nervous system disorders
Dysphasia
|
33.3%
1/3 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
15.4%
2/13 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified -Other
|
33.3%
1/3 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
30.8%
4/13 • Number of events 4 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, right sided
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Nervous system disorders
Nervous System disorders- Other
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
15.4%
2/13 • Number of events 3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Psychiatric disorders
Psychiatric disorders - Other
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
12.5%
2/16 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Infections and infestations
Lung infection - pneumonia
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Eye disorders
Eye disorders -Other
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Nervous system disorders
Stroke
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Investigations
Investigations - Other
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Musculoskeletal and connective tissue disorders
Facial muscle weakness
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Nervous system disorders
Nervous system disorders - Other
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Nervous system disorders
Nervous System disorders -Other
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Infections and infestations
Encephalitis Infection
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
Other adverse events
| Measure |
Dose Level 1: HFSRT With Pembrolizumab and Bevacizumab
n=3 participants at risk
Hypofractionated Stereotactic Irradiation (HFSRT) radiation therapy treatment (FSRT) given to participants over 5 days. 100 mg Pembrolizumab intravenous (IV) infusion every 3 weeks. 10 mg/kg Bevacizumab administered intravenously every 2 weeks.
|
Dose Level 2: HRSRT With Pembrolizumb and Bevacizumab
n=16 participants at risk
Hypofractionated Stereotactic Irradiation (HFSRT) radiation therapy treatment (FSRT) given to participants over 5 days. 200 mg Pembrolizumab intravenous (IV) infusion every 3 weeks. 10 mg/kg Bevacizumab administered intravenously every 2 weeks.
|
Participants Treated at Maximum Tolerated Dose
n=13 participants at risk
Hypofractionated Stereotactic Irradiation (HFSRT) radiation therapy treatment (FSRT) given to participants over 5 days. 200 mg Pembrolizumab intravenous (IV) infusion every 3 weeks. 10 mg/kg Bevacizumab administered intravenously every 2 weeks.
|
|---|---|---|---|
|
Psychiatric disorders
Hallucinations
|
33.3%
1/3 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
25.0%
4/16 • Number of events 7 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
23.1%
3/13 • Number of events 6 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
12.5%
2/16 • Number of events 22 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
31.2%
5/16 • Number of events 5 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
38.5%
5/13 • Number of events 6 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Psychiatric disorders
Anxiety
|
33.3%
1/3 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
12.5%
2/16 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
23.1%
3/13 • Number of events 4 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
18.8%
3/16 • Number of events 3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
23.1%
3/13 • Number of events 3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Nervous system disorders
Ataxia
|
33.3%
1/3 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
12.5%
2/16 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
12.5%
2/16 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
15.4%
2/13 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
12.5%
2/16 • Number of events 4 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Eye disorders
Blurred vision
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
15.4%
2/13 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Eye disorders
Cataract
|
33.3%
1/3 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
General disorders
Chills
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
18.8%
3/16 • Number of events 4 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
15.4%
2/13 • Number of events 3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Investigations
Cholesterol high
|
33.3%
1/3 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
12.5%
2/16 • Number of events 3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
53.8%
7/13 • Number of events 10 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
25.0%
4/16 • Number of events 4 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
23.1%
3/13 • Number of events 4 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
12.5%
2/16 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
15.4%
2/13 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Investigations
Creatinine increased
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
18.8%
3/16 • Number of events 4 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
12.5%
2/16 • Number of events 3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Psychiatric disorders
Depression
|
33.3%
1/3 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
25.0%
4/16 • Number of events 5 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
23.1%
3/13 • Number of events 4 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
18.8%
3/16 • Number of events 3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Nervous system disorders
Dizziness
|
66.7%
2/3 • Number of events 3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
31.2%
5/16 • Number of events 6 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
38.5%
5/13 • Number of events 7 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
15.4%
2/13 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
15.4%
2/13 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
18.8%
3/16 • Number of events 3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Nervous system disorders
Dysphasia
|
33.3%
1/3 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
23.1%
3/13 • Number of events 4 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
1/3 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
15.4%
2/13 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
General disorders
Edema limbs
|
33.3%
1/3 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
23.1%
3/13 • Number of events 3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Eye disorders
Eye disorders - Other, specify
|
33.3%
1/3 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
15.4%
2/13 • Number of events 4 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Eye disorders
Eyelid function disorder
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Nervous system disorders
Facial muscle weakness
|
33.3%
1/3 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
15.4%
2/13 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Injury, poisoning and procedural complications
Fall
|
33.3%
1/3 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
37.5%
6/16 • Number of events 7 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
23.1%
3/13 • Number of events 5 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
43.8%
7/16 • Number of events 9 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
38.5%
5/13 • Number of events 8 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
General disorders
Fever
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
25.0%
4/16 • Number of events 6 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
30.8%
4/13 • Number of events 8 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
General disorders
Flu like symptoms
|
33.3%
1/3 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
15.4%
2/13 • Number of events 4 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
General disorders
Gait disturbance
|
33.3%
1/3 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
31.2%
5/16 • Number of events 5 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
30.8%
4/13 • Number of events 5 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
31.2%
5/16 • Number of events 6 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
30.8%
4/13 • Number of events 5 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
18.8%
3/16 • Number of events 5 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
61.5%
8/13 • Number of events 10 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
18.8%
3/16 • Number of events 4 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
23.1%
3/13 • Number of events 5 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
33.3%
1/3 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
43.8%
7/16 • Number of events 12 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
53.8%
7/13 • Number of events 9 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
15.4%
2/13 • Number of events 3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
12.5%
2/16 • Number of events 10 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Vascular disorders
Hypertension
|
66.7%
2/3 • Number of events 4 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
18.8%
3/16 • Number of events 3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
38.5%
5/13 • Number of events 11 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
15.4%
2/13 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
12.5%
2/16 • Number of events 4 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
12.5%
2/16 • Number of events 3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
33.3%
1/3 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
12.5%
2/16 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
23.1%
3/13 • Number of events 4 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
33.3%
1/3 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
12.5%
2/16 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
30.8%
4/13 • Number of events 7 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
33.3%
1/3 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
25.0%
4/16 • Number of events 4 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
15.4%
2/13 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
12.5%
2/16 • Number of events 3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
30.8%
4/13 • Number of events 5 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Infections and infestations
Infections and infestations -Other
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
12.5%
2/16 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Nervous system disorders
IVth nerve disorder
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
General disorders
Localized edema
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
12.5%
2/16 • Number of events 4 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Investigations
Lymphocyte count decreased
|
33.3%
1/3 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
43.8%
7/16 • Number of events 21 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
69.2%
9/13 • Number of events 15 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Nervous system disorders
Memory impairment
|
66.7%
2/3 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
18.8%
3/16 • Number of events 3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
15.4%
2/13 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
18.8%
3/16 • Number of events 3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
23.1%
3/13 • Number of events 3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
12.5%
2/16 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
15.4%
2/13 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
33.3%
1/3 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
12.5%
2/16 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
15.4%
2/13 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
25.0%
4/16 • Number of events 8 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
38.5%
5/13 • Number of events 5 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
|
33.3%
1/3 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
15.4%
2/13 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Nervous system disorders
Nervous system disorders - Other
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
18.8%
3/16 • Number of events 5 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
23.1%
3/13 • Number of events 5 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Investigations
Neutrophil count decreased
|
33.3%
1/3 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
15.4%
2/13 • Number of events 3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
General disorders
Pain
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
37.5%
6/16 • Number of events 7 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
30.8%
4/13 • Number of events 5 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Infections and infestations
Papulopustular rash
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Nervous system disorders
Paresthesia
|
33.3%
1/3 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
18.8%
3/16 • Number of events 3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
15.4%
2/13 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Investigations
Platelet count decreased
|
66.7%
2/3 • Number of events 4 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
31.2%
5/16 • Number of events 9 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
23.1%
3/13 • Number of events 5 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
15.4%
2/13 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Renal and urinary disorders
Proteinuria
|
66.7%
2/3 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
37.5%
6/16 • Number of events 9 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
46.2%
6/13 • Number of events 6 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Psychiatric disorders
Psychiatric disorders - Other
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
33.3%
1/3 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
12.5%
2/16 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Cardiac disorders
Restrictive cardiomyopathy
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Nervous system disorders
Seizure
|
100.0%
3/3 • Number of events 3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
18.8%
3/16 • Number of events 5 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
23.1%
3/13 • Number of events 5 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Nervous system disorders
Sinus pain
|
33.3%
1/3 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 5 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
23.1%
3/13 • Number of events 4 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
12.5%
2/16 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
33.3%
1/3 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
15.4%
2/13 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Psychiatric disorders
Suicide Attempt
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
12.5%
2/16 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
15.4%
2/13 • Number of events 3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Nervous system disorders
Tremor
|
33.3%
1/3 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
18.8%
3/16 • Number of events 4 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
15.4%
2/13 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Nervous system disorders
Vasovagal reaction
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
12.5%
2/16 • Number of events 4 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Investigations
Weight gain
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Investigations
Weight loss
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
12.5%
2/16 • Number of events 21 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 6 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Investigations
White blood cell decreased
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
18.8%
3/16 • Number of events 4 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
12.5%
2/16 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other
|
33.3%
1/3 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
15.4%
2/13 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Gastrointestinal disorders
Abdominal infection
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
12.5%
2/16 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Nervous system disorders
Brachial plexopathy
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
12.5%
2/16 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Infections and infestations
Wound infection
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
18.8%
3/16 • Number of events 11 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
General disorders
Malaise
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
12.5%
2/16 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Infections and infestations
Meningitis
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/13 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
6.2%
1/16 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
15.4%
2/13 • Number of events 2 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Injury, poisoning and procedural complications
Intraoperative musculoskeletal injury
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Nervous system disorders
Stroke
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Investigations
Investigations - Other
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
0.00%
0/3 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
0.00%
0/16 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
7.7%
1/13 • Number of events 1 • Adverse events recorded day 1 of study treatment through 30 days following cessation of treatment, 37 months in total.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place